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.

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

Purpose:

Ensuring that the manufacturing and engineering processes adhere to quality standards and regulations.

• To monitor and control the production process, ensuring that any defects or deviations are detected and corrected early.
• To inspect the finished product to ensure it meets all quality specifications and standards.

Key Area of Responsibilities:

• Responsible for manufacturing quality assurance including in-process quality, semi-finished product quality, and outgoing product quality.
• Lead a team of inspectors and supervisors to ensure incoming materials met internal and customer specifications and requirements.
• Drive incoming quality assurance process improvement in efficiency and effectiveness
• Owner of Non-Conformities and Error Management Systems. Collaborate with Headquarters for any system upgrade or changes
• Responsible for non-conforming materials disposition and Material Review Board (MRB)/ Corrective Action Board (CAB) and drive robust corrective and preventive actions
• Drive robust manufacturing system and process quality to meet internal and customer requirements and expectations
• Perform analysis on non-conforming quality incidents and internal errors and provide recommendations to meet internal and customer requirements and expectations
• Support Customer Quality to investigate customer product complaints
• Be responsible for manufacturing quality KPIs and reporting to senior management
• Lead a team of engineers to drive NPI and First Article quality requirements and system
• Provide leadership and consulting advice in quality matters
• Plan and lead manufacturing process audit to drive root cause analysis for outgoing inspection lapses.
• Lead, train, develop, and coach Quality team members. Manage performance evaluation and strengthen the organization.

Qualification & Experiences:

• Bachelor in Engineering (Mechanical, Electrical, Electronics, Chemical) or Material Science.
• 5 years of experience in Quality Assurance function, at least 3 years as a quality leader with supervisory experience in the manufacturing environment.
• Strong knowledge and practice in 8D, SPC, MSA, FMEA, QFD, 6-sigma methodology, PPAP, change management.
• Good understanding of First Article Inspection requirements and expectations
• Strong in statistical knowledge and 6-sigma methodology. Certified Black Belt or Green Belt preferred.
• Strategic, creative and systemic thinking
• Excellent leadership and effective communicator with all levels of associates and management.

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

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

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

1. Maintain, monitor the implementation & update of relevant audit programs
2. Provide technical advice & support various departments
3. Conduct compliance inspections in production floor & warehouse, identifying key areas for improvements and advice corrective actions
4. Perform QA inspections for incoming/outgoing cargoes based on compliance requirements
5. Coordinate with suppliers to resolve non-conformances
6. Provide in-house training on compliance etc for various departments

Job Requirement

• Diploma in Food Science/Food Technology or related disciplines
• Strong knowledge in food safety, well verse in GMP/GWP
• Strong analytical & problem solving skills
• Excellent interpersonal & communication skills

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 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

- 1 year renewable contract

- Up to 3,000 + PB

- Monday to Friday: 9am – 6.30pm

- Novena

Responsibilities:

• Deliver Quality Assurance objectives by conducting regular call reviews and highlight any potential risk to management.
• Review 15 of closed sales calls per day for General Insurance Team.
• Backup for Auto Insurance for Call Review purposes.
• Promptly report any calls detected with potential quality issues (e.g. misrepresentation, fraudulent) to Management.
• Prepare, track and send Quality Assurance related reports to UOB management and team. (NMD, Service Quality Monthly, Penalty Points Table)
• Keep track on all the status of Quality Assurance Cases from beginning to end process and provide update to management on a timely manner.
• Weekly meeting with management to discuss on discrepancies and solutions for further improvements.
• Other ad-hoc duties as assigned by supervisor

Period:

• 1 Year Renewable Contract

Location:

• Novena

Working Hours:

• Monday – Friday (9.00am – 6.30pm)

Salary:

• Up to 3,000 + PB

Requirements:

• Good to have BCP and PGI Certificates.
• Preferably have quality assurance experience and insurance products knowledge.
• Meticulous and responsible team player.
• Proficient in Microsoft Office.
• Able to multi-task.
• Fast Learner and willing to learn on multiple Insurance Products.

Interested applicants, kindly email your detailed resume (MS Word format is preferred):

[email protected] (Reg No: R1549023)

Please ensure that applications sent through email are no bigger than 1Mb.

We thank all applicants for your interest but regret to inform that only shortlisted candidates would be notified.

Success Resource Centre Pte Ltd (EA License Number: 04C3201)
160 Robinson Road, #13-07/08/09 SBF Center, Singapore 068914

T: 6337 3183 | W: www.successhrc.com.sg

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

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals

Purpose:

• To be responsible for managing the interactions with third party organisations that supply QA incoming materials and/or services to GSK.
• To manage material release for incoming materials, supplier change notifications and new material management.
• To provide Quality oversight to logistics management and warehouse operations.

Key Responsibilities:

Supplier Management

• Provide QA oversight of Supplier management activities on site to achieve compliance with company policies and government regulations as assigned.
• To participate (Executive 1) and to represent the site (Executive 2) for Supplier Management business processes to drive improvements and share best practises across the GSK Vaccines network.
• Process owner/support supplier complaint process for QA incoming materials. Lodge supplier complaints and ensure suppliers identify the root cause and associated CAPA's to prevent recurrence of supplier quality issues.
• Review and track supplier-related CAPA for timely closure.
• Maintain inspection readiness, conduct supplier assessments for both new and current service providers in a timely manner.
• Maintain the approved supplier listing and audit schedule in a state of compliance and accuracy.
• Assess supplier change notifications in a timely manner and escalate where necessary especially in situations with supply impact.
• Initiate and review deviations/change control/CAPA associated with incoming material.

Executive 1: Minor deviations and CAPA

Executive 2: Minor, major deviations and CAPA

• Work closely with site user and Global stakeholders for Supplier management related matters

QA Raw Material Release and Warehouse oversight

• Support incoming material documentation review and release to recommend and confirm Usage Decision (UD) of raw material
• Ensure that material document file (MDF) is complete and accurate before disposition of material in SAP
• Ensure that system is in place for filing and archival of MDF
• Initiate and review deviations/change control/CAPA associated with incoming material releases.
• Ensure that all deviations/change controls are closed or assessed for impact on the release of the material prior to release the QA-controlled incoming material
• Provide QA oversight to warehouse such as attending warehouse tier, conduction GEMBAs, inspection readiness and warehouse related deviations, CAPAs and change control

Decision Making:

Proposals & Recommendations

• Propose improvements to work processes, with basic awareness of business requirements.
• Deviation investigations and assessments
• In addition for QA Executive 2:
• Able to provide QA oversight on routine situations independently and complex situations with supervision (deviations, changes, system issues, compliance matters)
• Able to manage simple department projects (e.g. continuous improvement) with supervision
• Greater awareness of business requirements and to highlight considerations where there is a need for escalation

Skills:

Professional

• At least University basic degree in a Science or Engineering discipline

Technical

• A good understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing
• User experiance with SAP will be prefered
• Ability in handling and organizing multiple workflows

Business

• Ability to apply optimal quality assurance standards to promote a business edge
• Ability to facilitate business activities commpatible to international regulatory environment
• Ability to communicate effectively within the site organization and across the network

Competencies:

• Working knowledge of FDA/EU/ICH/WHO as well as all other relevant reuglatory and technical guidelines
• Possess Analytical and Quality performance mindset
• Demonstrate professional & ethical integrity
• Fluency in the English language
• Demonstrates sense of urgency
• Ability to work both as an individual contributor and as a team player.

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
• Monitor EMO/supplier qualification, assessment and performance evaluation processes.
• Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
• Maintain and update internal audit program.
• Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
• Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
• Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
• Provide training and guidance to quality staff on quality documentation, including system – Veeva (QMS), compliance training system etc.
• Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
• Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

• Drive quality culture and promote GMP compliance behaviors to the site.
• Ensure site compliance to Quality Standards (QS) and ICH guidelines.
• Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards (PQS).
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
• Require working on rotating shift.

For interested candidates, please send your updated resume:

Email: [email protected]

Whatsapp: 96503173

Telegram: @jesswongie

Jessie Wong Yuan Si

R2197171

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

• 5 days work week
• Location: North

Job Scope:

• Take charge of our Integrated Management System, ensuring processes are documented, owned, and regularly improved.
• Lead internal audits by preparing schedules, conducting audits, reporting findings, and implementing corrective actions.
• Investigate non-conformances, pinpoint root causes, and implement effective solutions to enhance operational quality.
• Oversee compliance with QHSE standards, ensuring alignment with industry and customer requirements.
• Manage document control systems, keeping records accurate, up-to-date, and aligned with regulatory needs.
• Conduct internal training to ensure the team stays ahead in aviation-related standards and practices.
• Collaborate with cross-functional teams to monitor and report quality metrics, driving data-driven decisions.
• Lead quality investigations, identify improvement opportunities, and escalate key findings to management.

Job Requirement:

• A Diploma/Degree in Engineering, preferably in Quality Engineering.
• At least 2 years of hands-on Quality Assurance experience in the aviation industry.
• Proficiency with ISO standards (ISO 9001, ISO 14001, TS 16949) and statistical tools.
• Strong analytical mindset with excellent problem-solving and communication skills.
• Internal/Lead Auditor certification (preferred) and a passion for knowledge-sharing (Train-the-Trainer qualification is a bonus).

To Apply, kindly click on the "APPLY NOW" button

We regret that only shortlisted candidates will be notified.

Staffking Pte Ltd (20C0358) | Chong Kar Ming (John) (R21101412)

Job Description

• Lead and guide sub-contractor to achieve quality workmanship
• Handle paperworks , defects issuance and reporting
• Conduct defects investigation and identification

Requirement

• Minimum 4 years in CONQUAS
• Possess at least 2 good industry practices certificates
• Microsoft office knowledge
• Able to communicate with client and consultant

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.

Need to know Zeiss CMM Program

Need to Know Zeiss CMM Operation

Have Quality Assuarnce & Quality Control Knowledge

Know incoming / In-process / External provider parts insepection

Know prepare of quality documentation and maintenance documents like daliy Monitoring Data and Monthly Data performance

Will preapare of documentation for customer audit and ISO audit

DESCRIPTION

This is an exciting opportunity for you to be an integral part of the Quality Management department to optimise patient care and outcome.

The Administrative Executive is responsible for providing administrative support to ensure the smooth and efficient functioning of the department initiatives within the hospital. This role involves the coordination and maintenance of accurate records, meetings, and supporting the implementation of quality management projects.

RESPONSIBILITIES

Documentation Management:

• Maintain accurate and up-to-date records related to quality management.
• Organize and file documentation in compliance with regulatory standards.

Data Entry and Analysis Support:

• Assist in data entry for quality metrics and performance indicators.
• Generate basic reports and assist in data analysis under senior staff guidance.

Meeting Coordination:

• Schedule and coordinate meetings for the Quality Management team.
• Prepare meeting agendas and distribute relevant materials.

Communication and Correspondence:

• Facilitate communication between internal and external stakeholders including team members, other departments, external healthcare institutions, among others.
• Draft routine correspondence and respond to inquiries as directed.

Assist in Quality Projects:

• Support the implementation of quality management projects.
• Collaborate with team members to ensure project timelines and deliverables are met.

QUALIFICATIONS/REQUIREMENTS

• Minimum Diploma.
• At least 2 years working experience.
• Good speaking and writing skills
• Proficient in computer skills including Microsoft Office (e.g. Excel, Words etc.)
• Self-disciplined, motivated, self-starter, Meticulous
• Ability to work collaboratively in a team environment

Interested candidates, please apply with your updated resume, expected salary and notice period.

We regret that only shortlisted applicants will be notified.

NOTE: CRAWFURD HOSPITAL IS NOT IN COLLABORATION WITH ANY EMPLOYMENT AGENCY NOR CONSULTANT FOR OUR POSITIONS OPENING.

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

The summary of the scope of activity as below:

1. Revise and review SOPs

2. Review executed MBR/EBR

3. Support manufacturing team with any quality interpretation , queries and issues.

4. Provide quality oversight (participate GEMBA walk, GMP walk)

5. Perform archival of QO documents

6. Perform IQ and OQ. Involve in URS, design specifications

Requirements

• Min Degree in science / engineering related courses
• Min 2 to 3 exp of Quality experience from pharma / Medical industry
• Able to start work immediately

Up to $8K (For Senior role) x 1

Up to $6K (For junior role) x 1

Pharma MNC

Interested candidates, please forward your resume to [email protected]

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)