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.

• 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

Job Description

• Working with Process Engineer & Engineering team on QC requirement
• Documenting inspection criteria and quality plan
• Work with QA, Process and Product team on corrective action with quality issue
• Work with Process team on in-process audit and FQC audit

Job Requirements:

• Minimum Diploma in Manufacturing /Quality Engineering
• At least 1 year of relevant working experience in Electronics Product Manufacturing environment
• Control of Supplier Quality Assurance (SQA)
• Quality control of in-coming, in-process and out-going products
• Knowledge of ISO 9001, 14001, 13485 & 45001, FDA requirement
• Able to understand IPC requirement in PCB
• Assembly, quality requirement of plastic molding, die casting, extrusion, metal stamping and machining parts

*Please be notified that only shortlisted candidates will be notified*

By submtting your personal data and/or resume, you give consent to the collection, use, and disclosure of your personal data and/or resume by the company (or its agent) for the purpose of the processing and administration by the company relating to this job application.

EA Personnel Name: Chan Jun Wei

EA Personnel No: R1543992

EA License No: 21C0845

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

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 Scope

• Project management: analytical, raw material and microbiological method introduction and analytical equipment qualification
• Assist in regulatory filing and method launch
• Helping out in invalid results tracking, trending and investigation
• Conducting unexpected results investigation
• Control trend establishment and investigations
• Reference standard and reagent qualifications
• Conducting compendia review
• Assisting in audit preparation and involvement and other tasks as assigned.

Job Requirements

• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Six Sigma Greenbelt training would be helpful.
• Demonstrated experience e.g. in the area of method validation, method transfer, method verification.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

For interested candidates, please send your updated resume:

Job Description

1. Supervise a team of QC Officers in all factories.
2. Guide and troubleshoot for any equipment issues, co-ordinate with external service providers Ensure laboratory equipment is calibrated in a timely manner and update calibration records. Assist to keep, control, and confirm formulation and blending procedures.
3. Respond to new and existing customers for inquiries related to quality control Conduct quality testing and communicate product specification issues. Conduct nonconforming material or nonconforming product analysis.
4. Participate in the root cause analysis of nonconforming goods.
5. Follow the instructed corrective actions and preventive actions by superiors. Establish formulation and blending procedures as needed.
6. Keep and monitor retain samples of products
7. Validate COA of raw materials received and communicate any issues to the procurement and Plant Manager Establish, update and issue GHS SDS.
8. Create certificate of analysis (COA) of products.
9. Confirm and provide resources for the laboratory and other QCR needs.
10. Coordinate sample delivery as required by the customer.

Job Requirements

• Min. Degree in Chemistry related field or
• Diploma in Chemistry with minimm 5 years of relevant experience
• Technical Knowledge : Microsoft Officer (Basic) / Good knowledge & skills on QC testing
• Ability to coach and mentor the team

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.

We are seeking qualified and highly driven professionals to join our Quality Control Team. You will be required to support the Head of Quality Control in all aspects of operational/compliance audits/reviews in our office. This is to ensure our office complies with the firm’s system of quality management designed to comply with professional standards and regulatory and legal requirements.

Responsibilities

• Plan and conduct risk assessments and quality controls reviews to ensure compliance of all statutory, regulatory requirements and internal compliance requirements.
• Analyse and identify quality control gaps and validate that controls are operating effectively and timely.
• Provide/suggest refinements to improve controls and enhance quality control standards within the firm’s service lines and practices.
• Conduct independent reviews of audit engagements before audit opinions are signed.
• Carry out root cause analysis and monitor effectiveness of action plans to address quality and risk areas of weaknesses.
• Train, coach, develop and cultivate technical competencies to ensure capability of designated employees to maintain and comply with quality standards.
• Prepare and collate information/reports for regulatory and internal reviews and to handle any related coordination work.

Requirements

• Bachelor’s Degree in Accountancy or equivalent
• Minimum 5-8 years experience in an audit role in a large international or professional services firm.
• Experienced in quality reviews and/or internal audits preferred.
• Able to work independently and possess strong project management and analytical skills with the ability to work within a team in a fast-paced environment.
• Excellent presentation, written and verbal communication skills to communicate across all levels of staff and management.

In this role, you will:

• Job shadow / On-job training with the team to understand cable manufacturing and testing process
• Be involved in QC tests (Incoming Quality Control, In-Process Quality Control, Final Quality Control/Out-going Quality Control)
• Prepare technical reports based on customer’s required specification
• Develop and implement performance improvement and quality assurance programs
• Be closely involved in one or two projects relating to QC team’s productivity or digitalization efforts

Job requirements:

• Strong attentiveness to details as QC data requires accuracy
• Takes initiative in leading a task and will proactively check in when in doubt
• Basic knowledge in quality assurance or systems and/ or process optimization is a plus
• Proficient in MS Office (Excel, Powerpoint)
• Comfortable in working with data

*Kindly indicate the period you are able to commit to the internship in resume

*Only available for internship period beyond August

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 manage QC equipment life cycle from qualification to decommissioning including calibration and maintenance plan follow up

Key Responsibilities:

• Technical responsibilities
• Manage new QC equipment qualification as per change control and validation processes (i.e. URS, System classification, Audit trail review assessment, DQ/IQ/OQ, PPC09)
• Be author of SOPs/ protocols/ reports/ training materials
• Manage decomissioning of QC equipment and follow disposal
• process
• Maintain our QC asset listing up to date Follow QC equipment routine lifecycle
• Coordination of calibration and maintenance plan with user and external vendor/TS team
• Coordination of equipment troubleshooting if occurence of failure/breakdow (i.e. Tag in/out equipment, Work order creation)
• Sample transfer, alarm management and cleaning for fridges, freezers and incubators
• Liaise with external vendor for service quotation, escort vendor during service and approve invoice timely
• Supports compliance activities:
• Performs regular Ll audits in QC
• Coordinates and supports all L2, L3 and L4 audits and the associated CAPAs
• Lead and manage continuous improvement projects Subject-matter-expert (SME)/ audit fronter for assigned topics
• Manage ad-hoc tasks
• Organization and Management Responsibilities
• Creates strong team morale and a culture of accountability and ownership
• Provides leadership, guidance and technical expertise/support to the juniors
• Ensures continuous improvements of the QC operations
• Ensures expenditures are within budget
• Decision Making
• Proposals & Recommendations
• Based on experience & knowledge of work
• Proposal of CAPA for any issues/ deviations/ exceptions/ risks
• Proposal of QC improvement projects and strategies
• Team training and development

Skills:

Professional

• For Specialist - University Degree in a relevant Science discipline with at least 2 years of working experience or Diploma with at least 5 years of working experience
• For Senior Specialist - University Degree in a relevant Science discipline with at least 4 years of working experience or Diploma with at least 8 years of working experience

Technical

• Competent technical skills in project management
• Computer system validation Knowledge of cGLP & cGMP

Business

• Effective report writing skills
• Planning and Organizing skills
• Good interpersonal and communication skills
• Effective team player
• Analytical skills with logical thinking Problem solving skills

Competencies:

• Effective report writing skills
• Planning and organization skills
• Able to work independently
• Team player
• Analytical skills with logical thinking
• Leadership skills (advantage)
  ​​

Where will I be based?

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

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 perform testing and support related activities in QC Biological team

Key Responsibilities:

• Perform routine and adhoc/ non-routine testing in the following areas with good observation of GMP requirements:
• Biological testings for raw materials release (All QA controlled materials). Biological testings refer to biochemistry and/ or microbiological testings.
• Biological testings for intermediates and product
• Biological testings for utilities (city water, purified water, water of injection, compressed gases, etc)
• Biological testings required to support manufacturing process validations and confirmations
• Perform routine environmental sampling in controlled environmental areas
• Initiate and participate in laboratory investigation (OOS / deviations / atypical results / invalid results) and assist in timely closure of the investigation and CAPA
• Perform equipment calibration, maintenance and validation
• Participate in method transfer / verification / validation
• Participate in peer review for verification of task and data
• Assist in SOP writing
• Identify and report problems in QC to QC Superintendent in a timely manner
• Practice 6S and ensure good housekeeping of laboratory, work area and equipment
• Ensure good inventory of QC materials (purchased and prepared materials / glassware) to support testings; ensure no over surplus of inventory
• Ensure wastes are disposed appropriately and promptly
• Adheres to all safety and security policies and practices
• Assist the Senior Superintendent/Superintendent in the management and operations of the team; may be indirectly responsible for a team of associates:
• Scheduling day-to-day shopfloor activities and resources handling to ensure timely availability of test results
• Reviews test reports to ensure accuracy of test results in accordance with corporate, regulatory and external agency regulations.
• Provides training to the team.
• Provides guidance, support and technical expertise to the team.
• Involves in investigation and protocol writing (when required)
• Involves in SOP writing and updating
• Organization and Problem Solving:
• Creates strong team morale and a culture of accountability and ownership
• Recommends and coordinates appropriate corrective actions to quality problems in conjunction with other teams/ departments
• Presents in timely manner major issues to the management with strategies on their resolution.

Skills:

Professional

• For QC Associate, fresh graduate in NITEC/ Diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry
• For Senior QC Associate, NITEC/Diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry, with at least 2 years of working experiences or Fresh degree holder in Microbiology Biotechnology, Life Sciences, Chemistry, Biochemistry. Increased number of years of experiences are required for higher positions.
• For Lead QC Associate, NITEC/Diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry, with at least 8 years of working experiences or Degree holder in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry with at least 4 years of working experiences.

Technical

• Competent technical skills in the following:
• Good laboratory knowledge and hands-on experience in chemistry testings o Laboratory equipment qualification
• (advantage)
• Knowledge of cGLP & cGMP (advantage)

Business

• Effective report writing skills
• Planning and Organizing skills
• Effective team player
• Analytical skills with logical thinking
• Good interpersonal skills
• Leadership skills (advantage)

Competencies:

• Good command of English
• Good knowledge on usage of computers

Where will I be based?

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

This position is responsible for conducting audit checks to ensure that products meet the established standards, This role also supports the achievement of Company quality target.

1. Confirm to quality standard and quality processes

• Inspect in-coming and outgoing products according to policies standard.
• Perform all product processes within section (eg, QC,SAO), Reworks, Repairs, Defective photo-taking

2. Contribute to continuous improvement

• Maintain Integrity accuracy and completeness of Supplier invoice data and QC data in system
• Establish standard operating procedures and conditions for handling storage and checklist of stock.

3. Perform other ad-hoc duties as assigned.

Requirements

• At least 1 year of experience in Gold quality control in retail jewellery preferred
• If no QC experience in retail jewellery then at least 1 year of experience in QC control in manufacturing
• At least Diploma in any discipline
• Basic understanding of production methods.
• Attention to detail
• Able to use basic MS Office.
• Good Communication and Interpersonal Skills
• Able to multi-task and quick learner

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)

As an intern for the Assurance, your responsibilities include:

• Working as part of an audit team to complete, or assist in the completion of audit tasks which includes financial and statutory audits of companies
• Assist the team to perform analytical review of audit documents
• Assist the team with the preparation of supporting documents to support the opinion in the financial statements
• Assist the team with vouching of audit documents
• Assist the team to preform statutory reviews
• Assist the team to perform administrative works such as referencing, casting, indexing, etc.

Requirments:

• Training will be provided
• You must be a Singaporean or SPR, and able to commit for at least 3 months

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.

About Cynapse

Cynapse is an awarded AI Software Product company specializing in Enterprise-grade Vision AI in highly challenging environments. Our software platform is leveraging cutting-edge cloud/on-premises/edge platforms, advanced computer vision algos, advanced ML concepts & models and more.

The company is led by globally renowned experts who previously headed large groups at Microsoft and Intel. The company HQ is located in Singapore (One North Area) and operates in over 10 countries.

Cynapse is looking for a talented and highly motivated Project Management Officer (PMO)/Quality Assurance (QA) Intern to join our team that delivers challenging, enterprise-scale Video Content Analytics solutions to global customers. You will conform to high standards of project planning and management, working in a cutting-edge, dynamic and professionally challenging environment.

Successful interns may be offered a full-time permanent position at cynapse at the end of the internship period.

Responsibilities
The selected candidate will be involved in one or more job items listed below, depending on management decision:

• Supporting the planning and delivery of Vision AI Software Projects/Programs in Singapore and other countries
• Support multiple ongoing projects
• Assist with the project planning, resourcing and scheduling
• Assist in ensuring that projects are delivered on time, and provide timely reports on project status and activities Assist in requirements gathering and validation, solution development and testing, deployment, UAT and solution commissioning
• With guidance, perform usage tests on software thoroughly, identifying bugs and defects.
• Evaluate different functionalities and aspects of the product and generate reports.
• Assist in communicating and managing vendors, sub-contractors, partners and other stakeholders
• Follow the company PM best practices
• Work in an Agile environment (SCRUM)

Qualifications

• Completed at least 1 year of studies as part of a Diploma/Bachelor/Master in one of the following subjects: IT/Engineering/project management
• At least 6 months of experience in managing or delivering IT project/s
• Some Experience with vendors and partner management
• Analytical Thinking
• Innovative, motivated and a quick learner, attention to detail, curiosity, and passion for technology
• Bonus: Technical background/experience with software development

Benefits

• Unique opportunity to work with a talented global team on cutting-edge technologies
• Informal and exciting work environment with flexible hours

Job Types: Full-time, Internship

Contract length: 6 months

Benefits:

• Flexible schedule

Schedule:

• Monday to Friday

Work Location: In person

About the Role:

As the Senior Associate of Quality Operations, you will report to the Head of Quality Operations, APAC. Your role focuses on ensuring high-quality standards across our consumer healthcare product portfolio and fostering collaboration to drive a quality-focused mindset throughout the organization.

Key Responsibilities:

1. Product Quality Oversight

• Collaborate with manufacturing and distribution partners to ensure compliance with GMP and applicable standards.
• Manage quality processes, including product release (<3-day timeframe), OOS/NCR/Deviation/CAPA, and stability testing monitoring.
• Oversee change control, customer complaints, and quality investigations, ensuring compliance with regulations and SOPs.
• Support audits and due diligence for new manufacturers and products.

2. Quality Systems and Documentation

• Maintain and enhance the Quality Management System (QMS), including Change Control, CAPA, and Customer Complaints.
• Write, review, and authorize quality documents such as SOPs, work instructions, and investigation reports.
• Monitor performance metrics to ensure ongoing improvement of quality processes.

3. Collaboration and Stakeholder Engagement

• Drive a quality mindset across the organization by collaborating with internal teams and external partners.
• Act as an integral member of the Quality Ops team, supporting continuous improvement initiatives.
• Ensure quality activities align with regulatory requirements and corporate expectations.

Requirements:

To thrive in this role, you will possess:

• A BSc or equivalent in Chemistry, Pharmacy, or related Science/Engineering field.
• At least 5 years of experience in the pharmaceutical/medical device industry, with 3+ years in Quality Assurance.
• Strong knowledge of GMP, GDP, QMS, and quality processes (e.g., CAPA, deviations, change control).
• Experience in supply chain quality or manufacturing quality within a commercial business.
• High tolerance for ambiguity, adaptability to change, and a growth mindset.
• Excellent collaboration skills and the ability to manage multiple tasks in a fast-paced environment.
• Strong customer focus and the ability to work independently while delivering on business needs.

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

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 1-3 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]

Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

Salary

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Interested applicants may email resume to [email protected]

Jessie Hoe Huey Miin (CEI Registration No: R1103861)

Recruit Express Pte Ltd (EA: 99C4599)

• Position: Quality Assurance QA/QC Engineer (MUST BE from Marine Engineering)
• Location: North Bridge Road (Walking distance from Fort Canning MRT Station)
• Working hours : 5 days / Monday - Friday - 9.30am -5.30pm
• Salary (Commensurate with experience): Basic up to $ 3700 + AWS + 14 days Annual Leave
• Duration : Permanent
• Industry : Global leader in Marine Lifting Equipment

Main Responsibilities:

• Perform inspection of incoming products, materials or customer items according to job project requirement
• Perform initial inspection and raise report
• Perform in-process inspection according to procedures and customer’s specifications. Raise report whenever necessary. Measure and record the dimension of components/parts using measuring instruments and analyse the findings for discrepancy
• Perform final inspection of items including dimensional and NDT to ensure that all quality requirements has been achieved. Analyse result and decide the acceptance level of the final product
• Prepare and conduct Project Specific Quality requirements training to production Supervisors and Sub-contractors QC Personnel.
• Establishing Work Procedures and Instructions.
• Support QA/QC Manager for establishing WPS, PQR and WQT Qualifications.
• Act as Project Lead QA/QC and control the entire project Quality Assurance and Control activities during construction phase.
• Oversees the Inspector’s performance on the project towards monitoring and control of workmanship towards quality.
• Updating of Inspection status and records on daily basis.
• Attend weekly client progress review, Internal and Sub-Contractors meeting to discuss Quality issues.
• Liaise with client in relation to Quality on Project Specific.
• Schedule and conduct Project Specific Quality Audit as per agreed Plan.

Requirements:

• Degree in Engineering or Diploma in Mechanical/ Marine Engineering or equivalent
• Experience in handling project Audit and liaise with internal & external auditor
• Knowledge in structural fabrication, piping isometric drawing and materials
• Experience in piping line walk, reinstatement inspections by clear understanding of isometric drawings

Email to: [email protected] or call me at: 6398 5689 for more information.

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Jane Chua

Associate Consulting Director (APAC)

License no: 13C6684

EA Personnel: R2197224

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

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 that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Joy Yeow Zhi Qian

(CEI Registration No:R2096261)

Recruit Express Pte Ltd (EA Licence No: 99C4599)

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Joy Yeow Zhi Qian

(CEI Registration No:R2096261)

Recruit Express Pte Ltd (EA Licence No: 99C4599)