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.

Greg King

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