For my client – a leading Cell & Gene Therapy CDMO – I am looking for a QA Batch Record Reviewer to support batch record review activities and help clear a backlog in a fast-paced and growing team.
Job Description: As a QA Batch Record Reviewer, you’ll play a key role in ensuring compliance, quality, and efficiency in sterile manufacturing processes. You’ll oversee batch record review while supporting on-the-floor QA activities, contributing to a high-performing team that is increasing production capacity. This is a great opportunity to step into a dynamic environment, working with cutting-edge technologies in the CGT space.
Responsibilities:
Perform batch record reviews (paper-based) to ensure compliance with GMP and regulatory requirements.
Support deviation reviews and investigations, ensuring accurate documentation and follow-up actions.
Provide QA oversight on the shop floor, observing manufacturing runs and ensuring process adherence.
Work closely with manufacturing teams to increase QA presence on the shop floor.
Collaborate with cross-functional teams, ensuring smooth execution of production and quality processes.
Operate within key quality systems, including TrackWise, Moda ES, PAS EX, DMS etc.
Key Requirements:
Batch record review experience.
Experience in sterile manufacturing is essential.
Cell & Gene Therapy (CGT) experience is preferred.
Experience in deviation investigations and reviews
Practicalities
Location: Geleen, The Netherlands – onsite
Language: English.
Start Date: ASAP
Contract Duration: Until the end of the year (potential for extension).
Interested? We want to hear from you! If you’re excited by this opportunity, send your CV to Khanyi Mabena at k.mabena@panda-int.com or call her on +31 2020 44502.