Regulatory Affairs and Quality Assurance Intern

We're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team.

We are looking for an intern who can begin in May/Jun 2025, and can commit for at least 4 months.

Key Responsibilities

- Maintain and update regulatory documentation and records for submissions

- Ensure regulatory databases are current and compliant with regulatory requirements

- Compile and maintain post-market vigilance documentation

- Assist in CAPA investigations for customer complaints, non-compliance, and audit findings

- Implement corrective actions as needed

- Maintain QMS documentation and records

- Provide support for ad-hoc tasks and projects

Ideal Candidate

- Open to uni undergrad students from all faculties

- Strong interest in regulatory affairs and quality assurance

- Ability to work in a detail-oriented and organized manner

If you're eager to learn and contribute to our RAQA team, we encourage you to apply!

Responsibilities

• Monitor and evaluate the quality of channel operations processes to ensure compliance with organizational standards and guidelines. This includes performing sample checks on contact centre agents’ email response to citizens.
• Conduct regular audits, prepare quality reports, and recommend improvements to enhance efficiency and customer satisfaction.
• Develop and maintain quality control policies, training materials, and operational documentation.
• Collaborate with the team lead to identify root causes of process inefficiencies and implement corrective actions.
• Provide regular training and guidance to the operations team on quality standards and best practices.

Requirements

• Diploma or Bachelor’s degree in Quality Management, Business, or a related field.
• Minimum of 3 years of experience in quality assurance, preferably in a channel or operations environment.
• Detail-oriented with strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.

Angela Teh Ling Wei (CEI No.R1104464)

Contact Number:67860100

Email Address:[email protected]

Recruit Express Pte Ltd / EA Licence No: 99C4599

We regret only shortlisted candidates will be contacted

Roles & Responsibilities

The RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and regulatory strategies are effectively implemented and quality systems are maintained and improved.

Key Responsibilities:

(a) Prepare good quality technical documentation.

(b) Manage regulatory submissions for pre-market product registration, renewals, and amendments to ensure timely market entry and compliance.

(c) Stay up to date on evolving regulations and guidelines and provide guidance to internal teams on regulatory landscape.

(d) Monitor post- market surveillance and timely reporting to regulatory authorities.

(e) Prepare and support internal audits, regulatory inspections and audits by notified body, regulatory agencies, partners, and addressing any findings or non- compliance issues that arise.

(f) Support supplier management and audits.

(g) Manage and maintain the effectiveness of Quality Management System (ISO 13485).

(h) Develop, implement and maintain SOPs and quality processes.

(i) Provide training to employees on regulatory and quality requirements.

(j) Responsible for database, processes and systems within RAQA.

Qualifications and Competency

(a) At least Bachelor’s degree in Life Sciences, Biomedical Engineering or a related field.

(b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical device industry.

(c) In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc)

(d) Strong knowledge and understanding of ISO 13485, GMP, regulatory and quality standards

(e) Excellent project management, organizational and problem solving skills

(f) Strong attention to details with the ability to manage multiple priorities and deadlines.

(g) Excellent written and verbal communication skills

(h) Proficient in Microsoft Office

(i) Background in medical device manufacturing would be an added advantage.

Job Responsibilities:

• Support daily Quality Assurance activities, ensuring compliance with approved SOPs and policies in a multi-product, contract manufacturing facility.
• Provide quality oversight (participate GEMBA walk, GMP walk)
• Apply a solid understanding of cGxPs in a GxP setting, performing tasks with minimal supervision.
• Revise, review, and approve SOPs, protocols, reports, and records to ensure accuracy and compliance.
• Make real-time decisions on process events based on knowledge of SOPs and policies.
• Promote collaboration within teams to achieve objectives, demonstrating strong interpersonal skills.
• Perform other tasks as assigned by the supervisor to support the Quality Assurance department.
• Perform IQ and OQ. Involve in URS, design specifications

Requirements:

• Min Diploma/Degree in science related
• Knowledge of regulatory requirements and GMP quality systems.
• Experience in Quality Assurance in any industry

Interested candidates, do submit your resume to [email protected]

Attn: Ariel Fong Jea Yee (Outsourcing Team)
Audrey Chan Yu Jing (R1104782)

Recruit Express Pte Ltd (99C4599)

EA License No: 99C4599

EA Personnel No: R1761665

• 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 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:

Responsibilities

• Assist Product Owner, Business Analyst to craft out user story acceptance criteria
• Analyze and decompose complicated software systems, and design a holistic test strategy
• Research emerging technologies and develop test automation framework
• Develop test suites of test scenarios and test cases.
• Perform time-boxed exploratory testing
• Maintain regression test suite in QA nightly build
• Actively refine the smoke test suite in the Development CI environment
• Lead system integration testing with other systems
• Manage user acceptance testing
• Manage defect life cycle, test artifacts, and repository
• Drive continuous improvement in agile testing practices and tools.
• Improve software quality using XP practices such as code review and unit testing
• Understand the IT management policy, quality management policy and security guidelines to ensure the development processes, procedures and system are designed to comply with these policies and guidelines

Requirements

• Bachelor’s degree in computer science, Software Engineering, or a related field (Advanced degrees are a plus).
• Minimum of 5 years of professional experience in Software Quality Assurance.
• Proven experience with automation testing, particularly using Cypress for E2E testing.
• Hands-on experience with performance testing tools like Gatling and Autocannon.
• Experience with contract testing frameworks such as Pact.js.
• Proficiency in JavaScript (TypeScript) and familiarity with Go.
• Solid understanding of frontend and backend technologies, including ReactJS, ExpressJS, and Gin-gonic.
• Experience with AWS services, Docker, and Kubernetes.
• Familiarity with CI/CD pipelines using GitLab and ArgoCD.
• Knowledge of relational databases (MySQL, PostgreSQL) and caching solutions (Redis)
• Understanding of REST API, GraphQL API, JWT authentication, and Elasticsearch.
• Experience with logging and monitoring tools like Splunk or OpenSearch.

Interested applicants, please Email , and look for [email protected]

John (Joax) Wong

Recruit Express Pte Ltd

EA License No. 99C4599

EA Personnel Registration Number: R23117179

We regret that only shortlisted candidates will be contacted.

Job Summary

Responsible for promoting a quality program focused on patient safety, training, standards development, audits, and risk management. Monitor healthcare trends in quality, patient safety, and performance improvement. Stay updated on regulatory requirements for quality assurance and patient safety. Drive continuous service improvements through surveys, audits, and training.

Job Responsibilities

• Manage incidents, customer feedback/complaints, and implement preventive actions.
• Identify and apply improvements in service, clinical quality, and patient safety.
• Develop and conduct training to improve service standards and customer service culture.
• Track and report Quality Indicators (e.g., productivity, customer surveys, incidents).
• Assist in creating and reviewing quality management policies for compliance.
• Ensure compliance with ISO 9001 standards and maintain all relevant policies.
• Work with consultants to achieve and maintain certifications (e.g., ISO 9001, Bizsafe).
• Handle external communications with agencies like MOH/AIC and manage award submissions.
• Perform other tasks as assigned by the Manager/CEO.

Job Requirements

• Minimum Diploma, preferably Degree in any field.
• 3-5 years of experience in quality management, ideally in healthcare.
• Experience in quality assurance, patient safety, and PDPA.
• Knowledge of healthcare regulations and guidelines.
• Experience in Root Cause Analysis and Failure Modes Effects Analysis is a plus.

Apply now by sending your resume to [email protected]

We regret to inform you that only shortlisted candidates will be notified.

Ashley Loo | R2095115 | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

• 5 (five) years of experience in similar services in the Oil and Gas industry
• Expert understanding of planning software such as Primavera P6, MS Project, and Power BI
• Expert understanding of project management parameters such as WBS, Project Risks, Project Schedule, and others within the PMBOK area of knowledge
• Experience in developing, analyzing, and adjusting Schedule in Primavera P6 software for big or complex projects
• Experience in Critical Path Report issuance and analysis
• Execution of daily/weekly reports and activities controls
• Expert understanding of Key Performance Indicators (KPIs) and control curves (S-curves, Rundown curves)
• Advanced use of Office package software such as Power Point, Word, and Excel (preferably can create formulas, pivot table)
• Experience in FPSO construction and commissioning
• Good command in English language (both written and spoken)

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

Apply now!

Job Scope

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

Job Requirements

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

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

[email protected]

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

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

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

The Opportunity

• Opportunity to work with MNC Client
• 5 days' work week, Office Hours
• Working location: CBD

Key Responsibilities:

1. EN 9100 Certification Preparation:
   • Lead the deployment and implementation of EN 9100 standards within the new factory.
   • Develop and oversee the creation of required process documents, including Quality Manuals, flowcharts, procedures, and work instructions.
2. Process Optimization and Documentation:
   • Conduct process mapping to define and document process flows, interfaces, inputs/outputs, criteria, and KPIs.
   • Establish and maintain dashboards to monitor quality performance and ensure compliance with EN 9100 standards.
3. Auditing and Compliance:
   • Conduct internal and external audits in line with certification requirements (e.g., EN 9100, ISO 9001, ISO 14001, etc.).
   • Support and coordinate Management System Certification audits, ensuring successful outcomes.
4. Team Engagement and Communication:
   • Act as the primary point of contact for all quality-related activities, engaging with cross-functional teams to align actions with certification goals.
   • Drive team collaboration through effective communication, synthesizing information, pushing action plans, and ensuring feedback loops.
5. Continuous Improvement:
   • Identify gaps and areas for improvement within existing processes and implement corrective actions.

Required Qualifications and Skills:

Education and Experience:

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum of 3 years of experience in EN 9100or ISO 9001 standard deployment or operations.

Technical Skills:

• In-depth knowledge of EN 9100 standards (ISO 9001 knowledge is acceptable if complemented by relevant experience).
• Proven expertise in internal and external audits, with experience in certifications such as ISO 9001, EN 9100, ISO 14001, or ISO 17025.
• Strong process-oriented mindset with the ability to map processes, define KPIs, and develop dashboards.
• Proficient in creating and revising quality documentation, including manuals, flowcharts, and procedural instructions.

Next Step

Prepare your updated resume and expected package.

Simply click on 'Apply here' or email to [email protected] to drop your resume

All shortlisted candidates will be contacted.

Prasant Sirohi

EA Licence Number: 91C2918

Registration Number: R22106307

Job Description

1. Data Protection Compliance:

• Assist in reviewing, updating, and maintaining data protection policies and procedures.
• Ensure organizational practices comply with data protection regulations (e.g., GDPR, CCPA).

2. Data Inventory and Mapping:

• Help update and maintain records of processing activities (ROPAs).
• Assist in mapping data flows to identify risks and gaps.

3. Data Protection Impact Assessments (DPIAs):

• Support in conducting Data Protection Impact Assessments (DPIAs) for new or existing processes.

4. Training and Awareness:

• Help coordinate data protection training sessions for employees.
• Develop awareness materials on privacy and data security practices.

5. Incident Response:

• Assist in responding to data breaches, including investigation, documentation, and reporting.
• Ensure incidents are escalated to appropriate teams when necessary.

6. Auditing and Monitoring:

• Assist in internal audits and drills to identify data protection compliance gaps.
• Provide administrative support for external audits.

7. General Administrative Tasks:

• Maintain accurate records of all data protection-related activities.
• Prepare reports and presentations as required.

Job Requirements

• Minimum Diploma in a relevant discipline, preferably Degree in any discipline.
• Preferably undergone Fundamentals of PDPA and/or Practitioner Certification in Personal Data Protection.
• Experience in compliance/audits especially data protection compliance.

Apply now by sending your resume to [email protected]

We regret to inform you that only shortlisted candidates will be notified.

Ashley Loo | R2095115 | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

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

Apply now!

Job Scope

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

Job Requirements

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

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

[email protected]

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

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

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

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

Apply now!

Job Scope

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

Job Requirements

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

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

[email protected]

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

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

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

Key Responsibilities:

• Assess and verify aircraft engine parts for conformity to airworthiness criteria and technical specifications.
• Utilize appropriate tools, equipment, and methods to conduct thorough inspections of engine components, modules, and accessories.
• Implement inspection techniques, analyze data, and apply lifecycle principles and risk-based approaches to support the inspection process.
• Carry out detailed visual and dimensional checks, identifying issues and recommending necessary repairs.
• Perform in-process evaluations to ensure components maintain proper condition and precise measurements.
• Communicate any discrepancies and document all inspection procedures and outcomes.
• Conduct final checks on engine parts to confirm repairs and modifications meet all required standards and technical guidelines.

Qualifications:

• Engineering or Aerospace certification required.
• 2 to 5 years of experience in inspecting aero engine components.
• Expertise in spotting and interpreting defects that could impact safety or quality.
• Proficient in using measurement tools such as micrometers, vernier calipers, and gauges.
• Strong understanding of inspection standards, methods, and lifecycle principles.

Why Join Us?

• Contribute directly to the safety and reliability of the aviation industry.
• Work with state-of-the-art technology and equipment in a dynamic environment.
• Grow your career with numerous advancement opportunities.
• Be part of a team dedicated to excellence and innovation in aerospace engineering.

Interested applicants may send their resume to [email protected] or click APPLY NOW

Talentvis Singapore Pte Ltd | EA License No: 04C3537
EA Personnel Name: Ong Hui Shan (Gwen) | R1767800

Job Description:

• Develop and maintain quality management systems (QMS) in the pharmaceutical industry
• Ensure GMP compliance throughout manufacturing processes
• Conduct internal and external audits to evaluate processes and identify improvements
• Review and approve batch records, ensuring proper documentation and compliance
• Monitor batch control processes, investigating and addressing deviations
• Perform Installation Qualifications (IQs) and Operational Qualifications (OQs) for equipment and systems
• Manage Change Control processes, ensuring regulatory compliance for process changes
• Investigate deviations, identify root causes, and implement corrective and preventive actions (CAPA)
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance

Requirements:

• Min Bachelor's degree in Engineering/Chemical/Biochemistry/Life Sciences or any related discipline.
• Strong knowledge in GMP
• Prior experience in Pharma, Change/Batch Control
• Able to commence immediately

For interested candidates, please send your most recent and updated resume to [email protected]
or WA me at +6596698692

Alicia Cheong Ling Wei

R1104785

Recruit Express Pte Ltd

EA License No. 99C4599

Missions and Responsibilities

1.Manage the maintenance systems to achieve performance of all the control systems (DCS, PLC, SCADA, HMI) with the objectives of achieving continual gas supply to the customer, leveraging organizational capabilities in response to business needs of our customers.
2.Ensure all the maintenance activities / records are recorded and maintained in CMMS (CIS).
3.Prepare a monthly maintenance report.
4.Participate in the RCA for all the reliability issues and propose the preventive action plan.
5.Adherence to Job Order / Work Permit system and to maintain zero accident by complying to all Safety rules & regulations in accordance with AL IMS and Workplace Safety & Health Act.
6.Ensuring that the maintenance program is in place and aligned with the maintenance strategy
7.Ensure that operating manuals and facility SOPs are established according to the IMS program of the subsidiary
8.Responsible for quality and safety audit (E&I part), related SOP & RA
9.Provide operation support to execute and complete the PM/CM/SDM on time.
10.Response to address the issues to reduce the down time
11.Identify the critical spare parts and manage
12.Train the operation staff on DCS, PLC and SCADA

Reliability Enhancement Project

1.You will supervise the contractors in your field of competencies with emphasis on safety, quality, schedule, and cost;
2.And manage the interfaces between disciplines and subcontractors;
3.You will plan the mobilization of vendor representatives;
4.And prepare and implement site-specific working instructions and procedures regarding construction utilizing the Air Liquide standards;
5.You will ensure the quality of construction/installation works according to contract requirements;
6.And report safety deviations and data for the site.

Key Job Experience

1.Degree in Electrical/Electronics/Instrumentation/Control Engineering or equivalent.
2.Minimum 7 years of working experience in Gas/Chemical industry preferably.
3.Minimum 3 years experience in maintenance / service / commissioning Oil and Gas or petrochemical industry DCS system such as Yokogawa/Siemens/Honeywell
4.Working understanding of process equipment and technology used in the facility
5.Working understanding of mandatory regulatory requirements applicable to the operations of the facility.
6.Excellent problem solving skills
7.Customer-oriented approach
8.Experience in RCA methodology
9.Loop Testing and Commissioning.

Responsibilities:

• Mainly involved in credit control matters; accounts receivables & accounts payables (AR/AP).
• Follow up with the collection of non-payments, delayed payments and other irregularities.
• Liaise with customers on statements of accounts and invoices, issue dunning letter accordingly.
• Ensure prompt updating of receipts from customers.
• Maintain accurate records of all chasing activities.
• Timely month-end closing for accounts receivable function.
• Assist in annual audits.

Requirements:

• Diploma in Accounting/Finance or related disciplines
• 2 years of work experience in accounting/finance, preferably within a digital marketing agency environment but not a MUST HAVE.
• Analytical Skills and knowledge of accounting principles to analyze financial reports and forecast.

• Perform assurance engagement in compliance with professional standards - act with integrity and professionalism
• Use of data analytics tools to gather and analyse data
• Empathise and discuss client’s issues through good understanding of client’s business – develop business adviser mindset early, build good personal rapport with client in a business-like manner
• Be a passionate team member - clarify instructions to ensure work requirements are clearly understood; participate actively in promoting positive work life environment

Requirements:

• Bachelor's degree in Accountancy or professional accounting qualifications recognised by ISCA
• Proactive and committed to learn
• Possess initiatives
• Team player

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

Apply now!

Job Scope

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

Job Requirements

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

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

[email protected]

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

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

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

We are hiring Quality Control Specialist to be outsourced to our clients from reputable healthcare organizations.

Apply now!

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.

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

[email protected]

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

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

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

Core Responsibilities:

• Ensure the product and processes adhere to the Quality Management System (QMS) while complying with regulations from government agencies, aviation authorities, and customer requirements.
• Develop, review, and revise quality procedures and quality control instructions to maintain system efficacy.
• Collaborate with customers, vendors, and suppliers to address non-conformance issues, conduct root cause analyses, and implement effective corrective actions to minimize quality-related costs.
• Conduct internal audits to evaluate the quality systems, products, and processes in alignment with ISO9001, AS9100, and NADCAP standards.
• Perform vendor audits and on-site evaluations to ensure compliance and quality standards are met.
• Ensure strict adherence to customer and regulatory requirements across all operations.
• Lead initiatives to reduce the monthly Cost of Poor Quality (COPQ) and minimize material scrap rates.

Qualifications and Skills:

• Bachelor’s degree in Mechanical Engineering, Aeronautical Engineering, or a related discipline.
• At least 2 years of experience in Quality Management Systems, with expertise in ISO9001, AS9100, and NADCAP standards.
• Proficient in using problem-solving methodologies such as fishbone diagrams, Failure Mode and Effects Analysis (FMEA), and the 5-Whys technique.
• Strong ability to read and interpret technical drawings and specifications.
• Excellent analytical, problem-solving, and communication skills.
• Detail-oriented with the ability to multitask effectively in a dynamic work environment.
• Knowledge of NADCAP processes such as heat treatment, non-conventional machining, shot peening, and chemical processing is highly advantageous.

This role offers the opportunity to play a pivotal role in ensuring quality excellence, driving process improvements, and contributing to the organization's reputation for superior product standards.

**We regret to inform that only shortlisted candidates would be notified

Interested applicants may send their resume to [email protected] or click APPLY NOW

Talentvis Singapore Pte Ltd | EA License No: 04C3537
EA Personnel Name: Ong Hui Shan (Gwen) | EA Personnel No: R1767800

Why Join Us?

• Renowned MNC with excellent benefits and 2-3 months of bonuses.
• Clear career progression opportunities.
• Dynamic work environment in the chemical industry.

Key Responsibilities:

• Develop, implement, and maintain QEMS (ISO 9001:2015).
• Lead internal and external audits and certification processes.
• Analyze quality performance trends and drive continuous improvements.
• Manage customer audits, feedback resolution, and corrective actions.
• Oversee supplier/vendor onboarding, audits, and KPI improvements.
• Conduct ISO 9001 training and promote quality awareness.
• Ensure compliance in Warehouse, Drumming, Transport & Yard operations.
• Support change management and contribute to management reviews.

Requirements:

• Diploma/Bachelor’s degree in Quality, Science, or Engineering.
• 3-5 years of quality management experience, preferably in chemicals/logistics.
• ISO 9001:2015 auditor certification is advantageous.
• Strong leadership and problem-solving skills.
• Experience in supplier and customer quality management preferred.

Location:

• Jurong Island (Transport provided).

Apply now to advance your career with a global industry leader!

**We regret to inform that only shortlisted candidates would be notified

Interested applicants may send their resume to [email protected] or click APPLY NOW

Talentvis Singapore Pte Ltd | EA License No: 04C3537
EA Personnel Name: Ong Hui Shan (Gwen) | EA Personnel No: R1767800

Salary: up to $2400 (basic)

Duration: 1 year

Location: Tuas (bus pickups - Jurong East, Outram, CCK, Woodlands)

Working Hours: five day week. 2 weeks of Morning followed by 1 week of afternoon shift

Responsibilities include:

Monitor Product Quality Compliance

Perform routine and non-standard tests on materials, products and other Quality Control purposes using HPLC, GC, Empower system etc

* Identify OOS, deviations and quality problems

* Report testing activities and results

* Comply with Quality and HSE procedures when carrying out sampling and QC tests

Manage Laboratory Operations

* Follow the organization’s operational excellence model for laboratory work

* Perform routine calibration and maintenance of laboratory equipment

* Report equipment OOS issues and equipment purchase requests

* Maintain integrity, accuracy and completeness of QC data and records

Optimise quality and efficiency of department workflows and activities

* Assist in preparing and participate for laboratory inspections and audits

* Compile data to support business and performance metrics reporting

* Propose solutions to improve QC procedures, activities and workflows

* Gather information to support feasibility assessments of introducing new QC procedures, systems and equipment

Requirements:

- Minimum Diploma in chemistry or science or related course

- At least one year experience in QC lab. Knowledge in operating HPLC and Empower software added advantage.

- Requires to work on shift.

Interested candidates, please submit your resume to: [email protected]

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

[email protected]

The Assistant Manager (Research Quality Officer) will assist the Research Director to establish and promote a safe and high-quality research culture in KK Women’s and Children’s Hospital (KKH).

Job Scope:

• Conduct audits and oversee the KKH Research Audit Framework.
• Conduct study monitoring (if any) and oversee the KKH Research Monitoring Framework.
• Responsible for review of current research policy and procedures and work instructions pertaining to hospital requirements, PDPA, HBRA, Medicines (Clinical Trials) Act and Health Product Act, etc.
• Assist in various kinds of external audit and inspection, if any.
• Oversee quality management of research projects at KKH.
• Organize and conduct regular sharing sessions or training workshop for KKH research community.

Job Requirements:

• Degree in Nursing, Life Science or related discipline.
• Minimum 8 years' site coordinator experience or minimum 6 years’ clinical research/pharmacovigilance monitoring/audit experience.
• Advanced knowledge of trial procedures and regulatory requirements in managing clinical trial.
• Proven ability to conduct quality assurance quality control, internal and external audits in clinical trial process.
• Possess good people’s management skills.
• Advanced computer skills e.g., MS Office Word and Excel.
• Good presentation, training and teaching skills.
• Good time management skills with good multi-tasking capabilities.
• Candidate with CITI, ICH-GCP, professional accreditation by ACRP or SOCRA will be an added advantage.