Total 2,615 quality assurance manager job vacancies in Singapore

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

Job Description & Requirements

Review the inspection history to summarize the integrity status of the plant equipment and piping systems.

· Perform the scoping work and prepare the job pack for process piping and in-service equipment based on engineering assessment and annual inspection plan.

· Plan and carry out fixed equipment/piping inspection via on-stream risk-based monitoring programs and downtime inspection activities including corrosion under Insulation (CUI) and corrosion under pipe support (CUP) on process piping and equipment according to annual maintenance plan

· Identifying the areas of special concern and deterioration (e.g. Dead legs, injection points, mix points, corrosion under insulation and Low silicon Inspection).

· Supervision and coordination of all on-stream and shutdown inspection and NDT activities for static equipment and in-service process piping.

· Review of inspection test plan, WPS and method statement for any in-service repair work of piping and pressure vessels.

· Witnessing of PT, MPI, PMI, metallographic tube testing and Hydro static test for statutory equipment.

· Provide recommendations and timely updates on equipment degradation problems.

· Provide quality assurance on project construction and maintenance works to ensure compliance with applicable codes, standards and specifications.

· Preparation of final inspection reports with all findings, abnormalities and recommendations.

· Ensure quality of inspected items to meet project requirements and standards.

· Inservice inspections in refineries / Oil and Gas / Petrochemical industries, such as corrosion under pipe support (CUPS), corrosion under insulation (CUI), Injection & Mix points inspections.

· Read, understand project related ITP, procedures, specification requirements.

· Review documents and drawings as per specification • Knowledge / experience about Piping Isometrics, P & ID, general arrangement drawings, Structural drawings, Weld Maps, welding symbols, Cutting Plans, Quality control procedures, Base Materials, and welding consumables.

· Inspection, review of mill certificates, Material verification, Inspection of Pipes, Fittings, Flanges, valves, nipples, plate tubes as per respective materials specifications, Codes, Standards & Client Specifications. Inspection / Witness & Review Stage wise activities earlier stage of spool fabrication

· Knowledge in welding inspection

Eligibility Criteria

· Graduate Engineers with 3-6 years of relevant experience.

· Relevant Engineering Degree or Diploma in Mechanical, Petroleum/Oil/Gas, Civil, Chemical or Industrial Engineering are acceptable.

· Experience in Refinery and Oil & Gas must

· Experience in QA/QC and Knowledge in Non-Destructive Testing methods.

· Knowledge/experience in welding inspection, structural fabrication, piping Isometric drawing and piping materials.

· Work Independently and can work in Singapore and other countries.

· Fluent Reading, Speaking and Writing in English.

· Willing to commit 24 months contract/ project completion.

· Team Worker, Mature, Meticulous, Pro-Active Work Attitude & Work Independent.

· Energetic & Result Orientated.

Job Description & Requirements

Review the inspection history to summarize the integrity status of the plant equipment and piping systems.

· Perform the scoping work and prepare the job pack for process piping and in-service equipment based on engineering assessment and annual inspection plan.

· Plan and carry out fixed equipment/piping inspection via on-stream risk-based monitoring programs and downtime inspection activities including corrosion under Insulation (CUI) and corrosion under pipe support (CUP) on process piping and equipment according to annual maintenance plan

· Identifying the areas of special concern and deterioration (e.g. Dead legs, injection points, mix points, corrosion under insulation and Low silicon Inspection).

· Supervision and coordination of all on-stream and shutdown inspection and NDT activities for static equipment and in-service process piping.

· Review of inspection test plan, WPS and method statement for any in-service repair work of piping and pressure vessels.

· Witnessing of PT, MPI, PMI, metallographic tube testing and Hydro static test for statutory equipment.

· Provide recommendations and timely updates on equipment degradation problems.

· Provide quality assurance on project construction and maintenance works to ensure compliance with applicable codes, standards and specifications.

· Preparation of final inspection reports with all findings, abnormalities and recommendations.

· Ensure quality of inspected items to meet project requirements and standards.

· Inservice inspections in refineries / Oil and Gas / Petrochemical industries, such as corrosion under pipe support (CUPS), corrosion under insulation (CUI), Injection & Mix points inspections.

· Read, understand project related ITP, procedures, specification requirements.

· Review documents and drawings as per specification • Knowledge / experience about Piping Isometrics, P & ID, general arrangement drawings, Structural drawings, Weld Maps, welding symbols, Cutting Plans, Quality control procedures, Base Materials, and welding consumables.

· Inspection, review of mill certificates, Material verification, Inspection of Pipes, Fittings, Flanges, valves, nipples, plate tubes as per respective materials specifications, Codes, Standards & Client Specifications. Inspection / Witness & Review Stage wise activities earlier stage of spool fabrication

· Knowledge in welding inspection

Eligibility Criteria

· Graduate Engineers with 3-6 years of relevant experience.

· Relevant Engineering Degree or Diploma in Mechanical, Petroleum/Oil/Gas, Civil, Chemical or Industrial Engineering are acceptable.

· Experience in Refinery and Oil & Gas must

· Experience in QA/QC and Knowledge in Non-Destructive Testing methods.

· Knowledge/experience in welding inspection, structural fabrication, piping Isometric drawing and piping materials.

· Work Independently and can work in Singapore and other countries.

· Fluent Reading, Speaking and Writing in English.

· Willing to commit 24 months contract/ project completion.

· Team Worker, Mature, Meticulous, Pro-Active Work Attitude & Work Independent.

· Energetic & Result Orientated.

Job Description & Requirements

Review the inspection history to summarize the integrity status of the plant equipment and piping systems.

· Perform the scoping work and prepare the job pack for process piping and in-service equipment based on engineering assessment and annual inspection plan.

· Plan and carry out fixed equipment/piping inspection via on-stream risk-based monitoring programs and downtime inspection activities including corrosion under Insulation (CUI) and corrosion under pipe support (CUP) on process piping and equipment according to annual maintenance plan

· Identifying the areas of special concern and deterioration (e.g. Dead legs, injection points, mix points, corrosion under insulation and Low silicon Inspection).

· Supervision and coordination of all on-stream and shutdown inspection and NDT activities for static equipment and in-service process piping.

· Review of inspection test plan, WPS and method statement for any in-service repair work of piping and pressure vessels.

· Witnessing of PT, MPI, PMI, metallographic tube testing and Hydro static test for statutory equipment.

· Provide recommendations and timely updates on equipment degradation problems.

· Provide quality assurance on project construction and maintenance works to ensure compliance with applicable codes, standards and specifications.

· Preparation of final inspection reports with all findings, abnormalities and recommendations.

· Ensure quality of inspected items to meet project requirements and standards.

· Inservice inspections in refineries / Oil and Gas / Petrochemical industries, such as corrosion under pipe support (CUPS), corrosion under insulation (CUI), Injection & Mix points inspections.

· Read, understand project related ITP, procedures, specification requirements.

· Review documents and drawings as per specification • Knowledge / experience about Piping Isometrics, P & ID, general arrangement drawings, Structural drawings, Weld Maps, welding symbols, Cutting Plans, Quality control procedures, Base Materials, and welding consumables.

· Inspection, review of mill certificates, Material verification, Inspection of Pipes, Fittings, Flanges, valves, nipples, plate tubes as per respective materials specifications, Codes, Standards & Client Specifications. Inspection / Witness & Review Stage wise activities earlier stage of spool fabrication

· Knowledge in welding inspection

Eligibility Criteria

· Graduate Engineers with 3-6 years of relevant experience.

· Relevant Engineering Degree or Diploma in Mechanical, Petroleum/Oil/Gas, Civil, Chemical or Industrial Engineering are acceptable.

· Experience in Refinery and Oil & Gas must

· Experience in QA/QC and Knowledge in Non-Destructive Testing methods.

· Knowledge/experience in welding inspection, structural fabrication, piping Isometric drawing and piping materials.

· Work Independently and can work in Singapore and other countries.

· Fluent Reading, Speaking and Writing in English.

· Willing to commit 24 months contract/ project completion.

· Team Worker, Mature, Meticulous, Pro-Active Work Attitude & Work Independent.

· Energetic & Result Orientated.

Job Description

• Provides support on quality systems, processes, and procedures to ensure compliance with FM Contract, Company’s, and ISO policies.
• Responsible for preparing and conducting quality control checks, investigations for potential quality non-conformance, compliance concerns and recommend follow-up actions to mitigate such issues on Building Facilities including M&E Systems, Building Systems and soft services.
• Prepare report for management review and facilitate for follow-up actions required.
• Attend regular maintenance meetings on behalf of the Company with Clients and Clients’ Representatives.
• Lead the internal audit program for operation site include identifying opportunities for quality systems’ improvements and meet company’s quality objectives.
• Maintain good records and filing systems of reports for future reference and coordination

Job Requirement

• At least 3-5 years relevant working experience in Engineering, Facilities or Estates Management, Quality Management Systems, Quality Control or equivalent.
• Minimally Diploma in any Engineering field, Facilities or Estates Management or equivalent with knowledge in ISO Standards 9001, 14001 and/or 41001.
• Certified QMS Auditor / Lead Auditor in ISO or equivalent will be advantageous.
• Pro-active, independent yet service and team-oriented, and able to perform under pressure with minimal supervision.
• Strong interpersonal and communication skills with ability to work cross-functionally with different departments to meet timeline and objectives.
• Location is at Singapore Polytechnic
• 5.5 work day

Responsibilities

• Internal and external excursion management (MRB / Quality Claims)
• Customer data reporting
• Conduct Quality related training
• Support customer survey and audits
• Continuous improvement activities

Requirements

• Bachelor's degree in Engineering or Science.
• Strong systematic and analytical problem-solving abilities.
• Proactive attitude with the ability to handle multiple tasks simultaneously.
• Excellent communication skills and a collaborative team player.
• Understanding of system flow and databases; basic SQL knowledge is advantageous.
  

For Experienced Candidates:

• Proven experience with QA tools such as 8D, FMEA, fishbone diagrams, and AND.
• Solid working knowledge of Statistical Process Control (SPC) and auditing practices.

For Entry-Level Candidates:

• Willingness to learn and adapt to new QA tools and methodologies.
• Basic understanding of quality assurance principles and practices.
• Freshgraduate with part time working experience during Uni time (aside from internship) is a plus.

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

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

RESPONSIBILITIES:

• Develop and update the quality material database and ensure proper recording and documentation
• Ensure proper documentation of raw materials/ ingredients/ finished products & traceability in place
• Liaise with regulators on mandatory requirements and compliance related matters
• To provide internal and external customers with technical advice and/or documentation when required
• Assist in the maintenance of HACCP and BRCGS management system

REQUIREMENTS:

• Diploma / Bachelor's Degree in Food Science or related field.
• Good knowledge of Quality Management System (HACCP, BRC, ISO 22000)
• Good communication, Organizational and Analytical Skills
• Able to work in a team and independently

Job Responsibilities:

• Management of Quality Management Systems.
• Support and maintain relevant systems both internally and externally.
• Responsible for Documentation Control system and Audits.

Job Requirements:

• Good working experience.
• Precision manufacturing industry.
• Adequate understanding of Quality Management System.
• Team player with good initiative and proactive.
• Microsoft office.

Job Responsibilities:
- Maintains the Company Integrated Management System, ensuring all business processes are documented, have a designated owner and a plan for their maintenance, aligned to Survitec strategy and associated accreditation and/or regulatory frameworks.

- Perform internal audit procedure and schedule as per Department audit plans, to include the audit Scope, Objective and Criteria. Deliver the audit report including findings; agree on corrective actions with auditees and refer findings to the Manager.

- Investigate non-conformances using current and appropriate methods, systems, and procedures, taking action to solve immediate compliance issues.

- Identifies shortcomings in quality processes or outputs, identifies root cause and works with internal stakeholder to adjust processes or working practices to remove or mitigate any production quality issues; uses established change management programs to address issues and deliver sustained improvements.

- Attend aviation related training and create/refresh and update on internal company aviation training notes.
Conduct internal company training as per aviation requirements.

- Implements systems to ensure compliance with QHSE policies, group and Customer requirements; ensures audit, inspection and risk management are adhered to and embedded throughout the system.

- Document control system management, revision and updating.

- Defines and communicates the processes and schedule for audit, working with colleagues from the Quality function to ensure all supplier, operational, technical, health, safety and environmental audit activity is carried out as planned.

- Leads and participates in quality, non-conformance and customer complaint investigations.

- Provides written reports on audit and investigation findings, implements and monitors CAPA and improvement actions. Ensures findings are reported and escalated appropriately.

- Works with Survitec QHSE colleagues to develop tools and dashboards for the statistical analyses on which recommendations for improvement are based. Ensures outputs from QHSE reporting tools and dashboards are communicated to and understood by the business.

- Inform manager of audit findings and compliance issues, including capability gaps, workflow issues or matters requiring quality development or improvement.

- Any others tasks/projects as assigned by line manager from time to time.


Job Requirements:
- Degree/Diploma in Engineering (preferably Quality Engineering).

- At least 2 years of Quality Assurance experience in Aviation industry.

- Knowledge of ISO 9001, ISO 14001, and TS 16949.

- Proficiency in statistical tools and Microsoft Office.

- Strong analytical, problem-solving, and communication skills
Certified Internal/Lead Auditor (preferred).

- Train the trainer qualification will have added advantage.

Job summary:
Experience in marine and oll & gas sector.
Responsible for the assigned customer account, to ensure all product quality, process quality andsystem quality to conform with customers' specifications and internal quality system reauirements

Roles & Responsibilities:
1.To liaise with Customer Quality representatives on all Quality matters.
2.Lead the investigation on all Customer Quality Feedback, Complaints and CAR with internal cross.functional team for comprehensive root cause failure analysis and ensure closure with effectiveimplementation of corrective actions and preventive actions.
3. Monitor product quality performance and generate quality reports; chair monthly product qualityimprovement meetings to reduce the customer reject and field return rate for continual improvement!Identify Quality lmprovement projects and initiatives to drive Customer Satisfaction with Quality.
4.Establish with customer representative and internal team on New Product Quality plans, procedureswork instruction for overall auality control and coordinate implementatilon and maintenance of suchplans, procedures or instructions; conduct quality training/ cross training for QA inspectors.
5.Audit customer fabrication line for compliance to applicable standards and procedures in QMs andEMS

58 RECRUITMENT PTE. LTD. 19C9772 67026282

JOBSCOPE OVERVIEW

1. Represent QA/QC department in 2G Management Meetings or other meetings required by Directors.

2. Create and maintain standard operating procedure (SOP’s), protocols, guidelines that ensure consistency and efficiency throughout the QA cycle.

3. Acts as Committee of all ISO audits.

4. Supervise and manage QA/QC team and interns.

5. Conduct physico-chemical and microbiological test for Chemicals and Incoming Paper.

6. Liaise with suppliers and third-party agencies.

7. Provide technical support to the sales and marketing team regarding product specifications, sample requirement & others.

8. Document those methods in standard operating procedures (SOPs) and production records, quality assurance activities with internal reporting and audits.

9. Review and compile documents for Audits (Batch Record: Prod sheet, Quality control test Reports; FG and RM Reports, Mixing records).

10. Ensure that on time calibration program of equipment (mechanical and lab instruments, weighing scales and test weights) are executed.

11. Assist to do in compounding and mixing when Mixer Operator is on leave.

12. Liaise with Overseas factory (China and Indonesia) to ensure that product or service meets specified requirements.

13. Review method validation study reports, ensure proper documentation of findings, and assist in approval or re-validation recommendations. Prepare summary reports of validation activities, results, and recommendations for management review.

14. Investigate validation failures or deviations, identify CAPA, and ensure implementation. Collaborate with cross-functional teams to enhance the efficiency and effectiveness of validation activities.

15. Identify risks in testing methods, implement mitigation strategies, and ensure data integrity during validation to maintain accuracy, reproducibility, and regulatory compliance.

16. Review and approve method validation documentation, ensuring accuracy, completeness, and compliance with quality standards. Maintain up-to-date records of validation activities, deviations, CAPA, and ensure proper version control for all related documents.

17. Provide training on method validation processes and best practices, and support Production, QC and R&D teams in executing protocols and analyzing data accurately.

18. Any other area of responsibilities that the company deems necessary.

A. QUALITY CONTROL

1. Manage product complaints or non-conformances; thoroughly investigate process failure, determine the root cause, and take prompt corrective actions.

2. Conduct physical, physico-chemical test and microbial analysis of finished product.

3. Track the materials (chemicals and fragrance) that are present in the chemical room and know whether additional supplies need to be ordered.

4. Calibrate all equipment for In-house verification Example – pH meter, weighing scale etc. and arrange external calibration with external party.

5. Train new production operators in quality control.

6. Any other area of responsibilities that the company deems necessary.

B. LIAISE WITH SUPPLIERS (Services):

1. DI Water System Maintenance (Requirements: According to Contract): Loop Sterilization, UV-Lamp etc.

2. Complete Water Quality Testing (annual) by External Lab

3. Monitor the consumable supplies from different suppliers for DI Water (Column, filters, gauges).

4. Wet Wipes Monthly External Microbial testing

5. Monitor the annual cleanroom Certification.

6. External Calibration of Equipment

7. Any other area of responsibilities that the company deems necessary.

C. PRODUCT TECHNICAL SUPPORT

1. Support Export Sales and Marketing for preparation of documentation for regulatory use (COA, Ingredient’s list, FG and RM spec etc).

2. Collaborate with development, QC, and regulatory teams to plan, execute, and review method validation protocols, ensuring compliance with applicable guidelines (e.g., ICH, FDA, EMA) and company procedures, while meeting regulatory standards for intended use.

3. Support on the process validation on the manufacturing of the product.

4. Any other area of responsibilities that the company deems necessary.

General Responsibilities

• Ensure that all services provided by the centres meet or exceed internal standards and quality assurance guidelines.
• Conduct audits to ensure regulatory compliance, reviewing internal processes and procedures, and identifying high-risk non-compliance areas in line with regulatory standards.
• Participate in initiatives aimed at improving the quality of early childhood care and education at the centres.
• Ensure adherence to corporate identity and guidelines across all centres.
• Ensure that the team provides a safe, nurturing environment that fosters children's social, emotional, physical, and intellectual development.
• Promptly escalate any issues or concerns to management.

Licensing and SPARK Certification

• Familiarity with the ECDC Act.
• Familiar with the SPARK QRS-U framework.
• Ensure that all centres comply with regulatory standards.
• Develop action plans to meet Licensing and SPARKS criteria.

Policies and Procedures

• Oversee, track, and monitor the centres' corrective action plans, ensuring that principals, supervisors, and staff follow through and assess the effectiveness of these actions.
• Motivate the team to achieve operational efficiency, maintaining organizational capabilities without compromising quality standards.

Requirements:

• Diploma in Early Childhood Care & Education (ECCE) or a related discipline.
• Minimum 3 years of relevant experience in the field.
• Knowledge of quality/compliance management and early childhood regulations and standards.
• Experience with quality improvement systems.
• Strong analytical skills, attention to detail, and ability to review data effectively.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Preferably a Junior Executive specializing in Quality Control/Assurance or a related role.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No. 20C0270

Key Responsibilities

The successful incumbent will support the QA Manager in the following responsibilities.

• Ensure compliance with the Company’s food safety management system, QA standards, customer requirements, certification audits, and regulations for quality and food safety control processes.
• Support the Quality Assurance Manager (QAM) in preparing external and internal audits according to customer standards/contract requirements, and drive cross-functional teams to achieve targeted performance.
• Conduct site inspections to promote continuous improvement and adherence to Standard Operating Procedures (SOPs), hygiene, and food safety practices.
• Manage QA random sampling and microbiological testing for food samples, raw materials, water & ice, hand swabs, and Environmental Monitoring Program (EMP).
• Analyze data and follow up on unsatisfactory test results to identify potential causes of failure, recommend corrective actions for process improvement, and prevent recurrence.
• Prepare documentation related to all export matters in the capacity of Quality Person (QP).
• Develop training materials and conduct food safety trainings for operational staff.
• Review new product artwork to ensure regulatory compliance.
• Assist QAM in food safety incident management, including site investigations, testing, and preparation of incident reports.
• Support QAM in maintaining the ISO 22000/HACCP manual and QA documentation.
• Assist in the supplier approval program (supplier assessment/documentation review).
• Contribute to QA work plans and initiatives aimed at improving QA processes and food safety standards.
• Support Group QA, annual emergency exercises, and ad-hoc catering events as required.

Key Requirements

• Minimum Degree in Food Science/ Technology or other relevant fields.
• Minimum 2 year of QA experience in the food industry.
• Passionate in upholding food safety and possess good knowledge of Food Regulations, SFA requirements, GMP, and food safety management certifications (e.g., HACCP, ISO 22000, GFSI standards).
• Keen learning attitude, proactive, and decisive.
• Detail-oriented and meticulous with competency in report writing and presentation skills.
• Independent, committed and possess strong interpersonal communication skills
• Ability to multi task, handle stress in a fast-paced environment, and meet tight deadlines.
• Excellent interpersonal and communication skills.
• Collaborative and able to work effectively in a team.
• Must be comfortable working in a cold environment.

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• Min Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to: [email protected]

Alex Goh Hock Leong (R1763413)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

COMPANY DESCRIPTION

Beyondsoft International (Singapore) Pte. Ltd. was set up in 2007 and established as the regional headquarters for the Southeast Asia (SEA) and European markets in September 2015. Based on our vision of "Using technology to promote social progress, economic development and become a global customer preferred partner" and our concept of "Beyond your expectations", Beyondsoft is committed to provide our customers in countries along the "Belt and Road" with comprehensive solutions and products and creating commercial value for customers to realizing continuous businesses development.

Our core business includes:

1. IT development services providing customers with IT consulting, software research and development, software and hardware testing, system integration and operation and maintenance, data analysis and other services;
2. New retail solutions and products through intelligent products, helping small and medium-sized enterprises (SMEs) realize the digital transformation of their daily operations;
3. Internet of Things (IoT) platform and solutions comprehensive use of IoT, artificial intelligence, big data, cloud computing and other technologies to provide IoT solutions for intelligent upgrades in cities, parks, buildings and industries, to create a smart future.

RESPONSIBILITIES

• Define and implement QA strategies, test plans, and test cases for web applications.
• Lead and mentor a team of QA engineers, fostering collaboration with cross-functional teams.
• Oversee all testing phases, including functional, integration, regression, performance, and security.
• Implement automation frameworks and optimize testing tools for continuous testing.
• Manage defect tracking, root cause analysis, and resolution to ensure seamless delivery.
• Ensure compliance with security, accessibility, and regulatory standards for web platforms.

• Bachelor's degree in computer science or equivalent.
• Minimum 5 years' experience of working experience in software testing and 2 years in leadership role
• Proficiency with QA tools (e.g., Selenium, JIRA, Postman) and automation frameworks (e.g., Katalon Studio, pCloudy).
• Familiarity with Agile and Scrum methodologies, along with scripting or programming languages (e.g., Python, JavaScript).
• Experience with performance testing tools (e.g., JMeter, LoadRunner) and end-to-end QA for complex web applications.
• Strong leadership, problem-solving, and communication skills

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

We are hiring Contract Quality Assurance to be outsourced to our clients from reputable healthcare organizations.

Apply now!

Job Scope

• Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with company procedures and regulations.
• Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.
• Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.
• Act as Quality Representative: Participate in cross-functional projects as the Quality Systems and Validation representative.
• Provide Validation Expertise: Offer guidance on creating or updating validation documents, such as for analytical instruments and methods.
• Ensure Document Readiness: Ensure all qualification/validation documents are clear and inspection-ready.
• Support Ongoing Validation: Oversee the Master Validation Plan and support routine qualification activities.
• Collaborate Across Sites: Help standardize validation processes across multiple sites.
• Train and Coach: Develop training materials and provide support to team members and other departments.

Job Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering, Engineering, or related field.
• At least 2-3 years of experience in quality assurance, manufacturing operations, or validation in the pharmaceutical or biotechnology industry. Experience in equipment, process, cleaning, and computer systems validation is preferred.
• Strong understanding of FDA/EU cGMP requirements, including CFR 21 Part 11, and familiarity with PDA and ISPE GAMP guidelines.

All Interested candidates are invited to email your resume in MS Word format to:

[email protected]

Please include your full working experience, education background, notice period, expected salary.

Sheryl Tan
Outsourcing Team
Recruit Express Pte Ltd
Company Reg. No. 199601303W | EA License Number: 99C4599

We regret to inform that only suitable candidates will be shortlisted for an interview.

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

This includes:

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).

Roles & Responsibilties

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

Quality Assurance Manager (Biopharma/CBD/1 Year Contract)

Role Purpose:

The Responsible Person, Quality Assurance Manager Australia and New Zealand, will work collaboratively with relevant stakeholders to implement & maintain the local Australian and New Zealand QMS and will work with internal & external stakeholders to ensure quality requirements are met for organisation products, throughout the distribution network, and within Australia and New Zealand, all the way to patients.

Key Responsibilities:

• Establishes and maintains the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and organisation expectations.
• Support maintenance of relevant licenses.
• Manages local process of change control, deviation, CAPA, complaint management and supplier management.
• Manages local Quality Management Review process.
• Participates in organisation’s Quality Escalation process for critical quality issues, and regulatory compliance issues.
• Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
• Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
• Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
• Reviews Annual Product Quality Reports (if applicable)
• Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
• Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
• Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
• Working with 3PL/4PL, provides guidance on supply related issues.
• Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
• Supports the management of quality and distribution complaints.
• Supports the investigation of fraudulent and counterfeit medicinal products.
• Manages product return and destruction.
• Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
• Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
• Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
• Assure customers validations and adequate records compliance to organisation QA requirements are established and maintained for all local distributors/customers.
• Collaborates with RA to support inspections and audits.
• Manages the Affiliate self-inspection program.
• Supports audit of distributor (where applicable).
• Collaborates with RA to implement activities for new product launch and product life cycle management.

Knowledge, Experience & Skills:

• Highly organized individual with a strong work ethic and ability to work flexibility and independently.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
• Demonstrates a knowledge of regional/local regulatory requirements and industry standards.
• Demonstrates strong verbal, written, and interpersonal skills in English.
• Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Typical Educational Experience & Competencies

• Bachelors’ degree and 7+ years of relevant experience in a GMP or GDP environment-related field
• Masters’ degree and 5+ years of relevant experience in a GMP or GDP environment related field.
• Ability to work on own initiative as well as display strong teamwork skills.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
• Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao

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We believe that challenges are better solved together. That's why you'll join a diverse, global community of solvers - an unexpected mix of people that come together to build trust in society and solve important problems. With us, you are encouraged to lead with your heart and values, and where your unique skills are developed and put to work in unexpected and exciting ways, superpowered by technology.

Our General Assurance Practice works with organisations to navigate regulatory complexities by improving their corporate reporting, and supporting their compliance with regulatory requirements and contractual agreements. As one of the world's leading global network of audit firms, our clients include leading companies listed on the Singapore Exchange (SGX), MNCs and emerging companies in Singapore. As part of the firm’s largest line of service, we thrive in a dynamic and fast-paced working environment, helping clients across industries, interacting with every aspect of their activities, understanding their business to identify areas to add value and offer insightful audit advice.

About you

• A degree in Accounting or related field
• At least 5 year of experience in the audit field (preferably gained at a Big 4 firm)
• Excellent analytical skills
• Strong team working skills
• Excellent verbal and written communication skills
• An ability to work effectively in a fast paced and dynamic environment
• Good project management and interpersonal skills
• Keen business awareness

Thank you for your interest in developing a career with PwC Singapore.

Only shortlisted candidates will be notified due to the high number of applicants for this role.