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Senior QA Specialist - ADC Manufacturing
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Senior QA Specialist - ADC Manufacturing
Job summary
A global leader in pharmaceuticals is seeking a Senior QA Specialist in Singapore. This role involves ensuring compliance in ADC manufacturing processes and requires over 5 years of experience in Quality Assurance within the pharmaceutical or biotech industries. A scientific degree and strong knowledge of GMP and international regulations are essential, along with solid communication skills. The position requires a full on-site presence and proficiency in Mandarin is a plus.
Qualifications
- 5+ years of experience in Quality Assurance within the pharmaceutical or biotech industry.
- Specific background in QA oversight of CDMO activities.
- Strong knowledge of GMP and international regulatory requirements.
Responsibilities
- Provide specialized QA support for documentation review and approval.
- Ensure GMP compliance of ADC manufacturing processes.
- Collaborate with internal teams on technical decisions.
Skills
Education
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our constant growth, we are looking for a Senior QA Specialist – ADC Manufacturing to support a strategic project for a client in Singapore.
- Providing specialized QA support for the review, approval, and oversight of documentation produced by a CDMO in China for the manufacturing of multiple ADC batches.
- Reviewing and approving analytical documentation, including:
- Analytical method procedures
- Qualification/validation protocols and reports
- Reviewing and approving manufacturing documentation, including:
- Master Batch Records (MBRs)
- In-process testing protocols
- Specifications
- Sampling plans
- Comparability protocols/reports
- Stability protocols/reports
- Executed batch records
- Assessment reports
- Label proofs
- QA declarations
- Certificates (CoA, Certificate of Compliance, CoT)
- Release sheets
- Ensuring GMP compliance of ADC manufacturing processes and adherence to company quality policies.
- Monitoring, assessing, and guiding QA oversight activities related to the CDMO, ensuring high quality standards and regulatory compliance.
- Collaborating with internal teams (CMC, QA, QC, Manufacturing) to ensure effective alignment on technical and documentation-related decisions.
- Supporting audits or inspection activities related to ADC operations at the CDMO.
- Degree in a scientific discipline (Chemistry, Biology, Biotechnology, Pharmacy, or related fields).
- Solid experience (preferably 5+ years) in Quality Assurance within the pharmaceutical or biotech industry.
- Specific background in QA oversight of CDMO activities, with hands-on experience in ADC (Antibody–Drug Conjugate) manufacturing due to its complexity.
- Strong knowledge of GMP and international regulatory requirements.
- Ability to critically assess technical documentation and manage QA approvals.
- Excellent communication skills and the ability to work effectively within cross-functional teams.
- Mandarin proficiency is a plus.
Location: Singapore, Tuas area
Availability: Full on-site
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.