We are seeking an experienced QA Lead / QA Approver to join a GMP-regulated biotech/pharmaceutical manufacturing environment on a contract basis. This is a key quality role supporting manufacturing operations, investigations, and batch certification activities.
Role Overview
As QA Lead / QA Approver, you will operate as an independent quality representative within a GMP manufacturing setting. You will provide QA oversight across deviations, investigations, CAPA, change controls, and batch record review, ensuring compliance with regulatory and internal quality standards.
Key Responsibilities
- QA approval of deviations, incidents, and non-conformances
- Leading and reviewing root cause investigations
- Oversight and QA approval of CAPAs and Change Controls
- Review and approval of Electronic Batch Records (EBR)
- Experience working with Master Batch Records (MBR)
- Compilation and final review of batch release documentation
- Acting as the QA representative during production scale-up activities
- Providing hands-on GMP quality support to manufacturing teams
Required Background & Experience
- Strong GMP QA experience within biotech or pharmaceutical manufacturing
- Proven hands-on experience managing deviations, investigations, and CAPA systems
- Demonstrated experience with EBR review and batch documentation
- Comfortable acting as an independent QA approver in a regulated environment
- Strong knowledge of GMP compliance and inspection readiness standards
Highly Desirable
- Experience in ATMP, cell therapy, or viral vector manufacturing
- Prior involvement in scale-up or technology transfer activities
Contract Details
- Contract position
- Competitive daily rate
- On-site/hybrid (depending on project requirements)
- Immediate or short-notice availability preferred
Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
