Total 75 quality assurance job vacancies in D02 Anson, Tanjong Pagar

Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEA

Opportunity:

Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Your Contribution:

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead and support various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

What we look for in you!

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)

2. Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Your competencies:

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Mon to Fri 8.30am - 5.30pm

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. Knowledge of cable product testing is an added advantage.

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

JOB DESCRIPTION:

-Works well with team members in performing audit assignments

-Prepare working papers to document audit files and reports for review

-Be responsible for planning, executing and documentation of audit fieldwork

-Document purpose, procedures and conclusion for all audit procedures performance

-Follow up on outstanding matters and findings independently.

REQUIREMENTS:

-Degree in Accountancy (ACCA, CPA)

-Proficient in Microsoft Especially Excel

-Sound Knowledge of Audit standards

-Meticulous, resourceful, independent as well as great team player

-Proficient in the English language

**Experience with Big Four accounting firms is a major advantage.

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. Knowledge of cable product testing is an added advantage.

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Prism is an independent audit, tax and business advisory firm committed to deliver "one-stop" professional services. Our integrated services are tailored to help clients grow, protecting their businesses, and ensuring their prosperity.

Experienced Audit Associate/Audit Senior

Job Description

1) Carrying out the audit relating to a portfolio of companies across a broad spectrum of industries, prepare appropriate audit work papers;

2) Understanding the relationships between objectives of the audit sections, the need for the sufficiency of audit evidence, and presentation of the conclusions

3) Review of financial statements in accordance with Singapore Financial Reporting Standards (SFRS) or SFRS for SMEs.

4) Communicate effectively and proactively to respond to clients and team members.

Job Requirements

1) Candidate preferred to possess at least Bachelor's Degree/ Post-Graduate Diploma/Professional Degree in Accountancy or equivalent.

2) Minimum 1 or 2 years of related working experience, for Audit Senior, minimum 2 to 3 years of relevant work experience.

3) Good knowledge in IT processes, MS Office

Positive attitude, meticulous, organised and able to work independently.

Mon to Fri 8.30am - 5.30pm

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Job Description

• Responsible for daily laboratory activities, including in-process analyses, certifying tanks for product sales and laboratory support for ad-hoc projects.
• Participate in laboratory’s safety programs and maintain compliance to safety regulations and company’s safety standards.
• Develops working knowledge of analytical instruments and build foundation in instrument troubleshooting.
• Writes technical documents to describe accomplished work.
• Develops good communication skills and interface with other operations.
• Develop basic understanding of processes to facilitate daily analytical work.

Qualification：

• Minimum Diploma in Chemistry, Science or Chemical Engineering.

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. Knowledge of cable product testing is an added advantage.

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. Knowledge of cable product testing is an added advantage.

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Description
We are seeking an experienced and highly motivated Healthcare Quality Manager to join our dynamic team to oversee and enhance the quality standards across our clinical and operational processes. This role offers a unique opportunity to work closely directly with the CEO and top-level management and contribute to the company's strategic vision within the healthcare industry. This role will be responsible for ensuring compliance with healthcare regulations, improving patient care outcomes, and optimising operational efficiency. The ideal candidate will bring a strong background in healthcare quality management, a passion for continuous improvement, and the ability to drive initiatives that ensure the highest standards of care.Develop, implement, and maintain quality assurance programs tailored to the clinical and hospital environment.
Collaborate with clinical teams, operational managers, and leadership to identify areas for improvement and implement evidence-based solutions.
Conduct thorough audits, inspections, and evaluations to ensure clinical processes adhere to regulatory standards (e.g., Joint Commission, CMS).
Analyse clinical data and operational metrics for trends and performance anomalies, driving quality improvements in patient safety and care outcomes.
Ensure the quality and efficiency of clinical operations, working closely with relevant teams to align with industry standards and patient care goals.
Provide detailed reports and direct feedback to executive leadership regarding quality metrics and clinical outcomes.
Oversee and audit clinical and operational quality, ensuring that all procedures meet healthcare regulations, standards, and internal policies.
Develop, implement, and monitor quality assurance and improvement plans across all departments.
Ensure compliance with all regulatory bodies (e.g., JCI, Ministry of Health) and maintain up-to-date knowledge of relevant regulations.
Lead the organisation in accreditation and certification processes, including preparation and follow-up on assessments.
Collect, analyse, and present quality performance data, providing actionable insights to drive continuous improvement.
Implement and track key quality performance indicators (KPIs) for both clinical outcomes and operational efficiency.
Facilitate training programs to ensure staff understand and adhere to quality standards and best practices.
Foster a culture of safety, quality, and compliance throughout the organisation.
Conduct regular internal audits to monitor compliance with internal and external standards and recommend corrective actions where needed.
Stay updated on industry trends and best practices in healthcare quality management to continuously refine and improve processes.

Requirements
A minimum of 6 years of proven experience in clinical operations and quality management, or similar role in the healthcare sector.
Strong knowledge of QA methodologies, tools, and regulatory standards applicable to healthcare.
Experience designing, implementing, and managing quality assurance programs in compliance with healthcare regulations.
Excellent communication skills with the ability to work collaboratively with healthcare professionals and influence decisions at a senior management level.
Strong analytical skills with a focus on data-driven decision making in clinical operations.
Familiarity with regulatory bodies such as the Joint Commission, CMS, and other healthcare compliance standards.
In-depth knowledge of healthcare regulations, quality standards, and accreditation processes.
Strong analytical and problem-solving skills, with the ability to interpret complex data and provide actionable recommendations.
Excellent interpersonal and communication skills, with the ability to work collaboratively across teams.
Certification in Healthcare Quality (e.g., CPHQ, Lean Six Sigma, or equivalent) is preferred.
Strong project management skills with the ability to lead initiatives from conception to completion.
Familiarity with quality improvement methodologies (e.g., Plan-Do-Study-Act, Lean, Six Sigma).

Benefits
Work in a diverse environment with people from over 10 countries
A generous leave policy
Work flexibility
Medical coverage
Annual Wage Supplement (Bonus)
Christmas Leave (The team takes the whole Christmas week off separate from our leave policy)
Birthday Leave (1 day)
Holidays off
Quarterly mental health day off
Mental health benefits (Premium access to our app!)
Work-life balance and employee wellness
Regular social events where we have non work-related fun

Apply for this job

Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEA

Opportunity:

Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Your Contribution:

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead and support various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

What we look for in you!

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)

2. Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Your competencies:

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Mon to Fri 8.30am - 5.30pm

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Job Description

-Leads team members in performing audit assignments

-Prepare working papers to document audit files and reports for review

-Be Responsible for planning, executing and documentation of audit fieldwork

-Document purpose, procedures and conclusion for all audit procedures performance

-Follow up on outstanding matters and findings independently

REQUIREMENTS:

-Degree in Accountancy (CPA)

-Proficient in Microsoft Especially Excel

-Sound Knowledge of Audit standards

-Meticulous, resourceful, independent as well as great team player

-Proficient in the English language

-Experience with Big Four accounting firms is a major advantage.