Location: Moleac Pte Ltd Helios #09-08 11 Biopolis Way Singapore 138667
Employment Type: Full-time
Industry: Pharmaceutical / Health Products / Traditional Medicine
Experience Level: Mid-level (3-5 years)
About the Role
We are seeking a proactive and detail-oriented Quality Assurance (QA) Specialist to join our team. The successful candidate will be responsible for supporting and monitoring the effective implementation and maintenance of quality systems, ensuring compliance with applicable GMP, GDP, and internal standards across all outsourced manufacturing and supply chain activities.
Key Responsibilities
- Plan and lead supplier audits for contract manufacturers and material suppliers as part of supplier qualification and periodic performance evaluations, in coordination with with relevant departments.
- Prepare and maintain quality agreement, documenting the defined roles and responsibilities of contract givers and contract acceptors in compliance with applicable GxP requirements, and conduct periodic reviews to ensure continued alignment and compliance.
- Develop, review, and maintain QA-related SOPs and documentation, covering areas such as contract activities management, supplier qualification and performance review, and Annual Product Review (APR).
- Maintain an organized and GDP -compliant documentation system, serving as a documentation controller to ensure traceability and regulatory readiness.
- Own and maintain the approved supplier and material list, ensuring updates reflect current qualification status and compliance with regulatory requirements.
- Participate in cross functional risk assessments, contributing to the identification and mitigation of quality and compliance risks.
- Plan and conduct self-inspections in accordance with GDP requirements to monitor internal compliance and drive continuous improvement.
- Support product complaints investigation and management, collaborating with the CMC team to ensure timely resolution and proper documentation.
- Coordinate with other departments on evaluation of deviation requests, ensuring risk and impact are properly assessed and documented.
- Propose and implement improvements to the Quality Management System (QMS), ensuring alignment with evolving regulatory expectations and operational efficiency.
- Back-up for product release responsibilities:
- Provide temporary or ad-hoc support to QC activities
- Review and verify COAs, batch release documents, and laboratory records from Contract Testing Labs (CTLs).
- Support coordination of sample submissions for raw materials, finished products, and stability testing to external labs, ensuring proper documentation and chain of custody.
- Assist in investigating out-of-specification (OOS) and out-of-trend (OOT) results in collaboration with CTLs, ensuring timely escalation and documentation.
- Monitor and track testing timelines to ensure timely release of products and materials.
- Maintain and archive QC-related documentation in compliance with GDP standards.
Qualifications and Requirements
- Bachelor's degree in Pharmacy, Life Sciences or related field.
- Minimum 3 years of QA experience in pharmaceuticals or other health products industry.
- Good working knowledge of GMP, GDP or similar quality management system.
- Experience working with contract manufacturers is an advantage.
- Strong attention to detail and documentation accuracy.
- Good communication and coordination skills, especially across cross-functional teams.
- Ability to work independently and manage multiple tasks under stipulated timelines.
- Flexibility to travel overseas for business-related assignments including supplier audits.
- Excellent writing skill.
- Detail oriented, organized and proactive.
- Continuous Improvement mindset.
- Proficiency in written and spoken English and Chinese (for bilingual documentation & correspondence).
What We Offer
- A collaborative work environment committed to quality and regulatory excellence.
- Opportunities to gain exposure to regional and international markets.
- Competitive salary and benefits package.
- Career development and learning support.
