Specialist Batch Record Review - Pharma | Specialist Batch Record Review - Pharma (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
This role involves ensuring the quality and compliance of biopharmaceutical products by meticulously reviewing batch manufacturing documentation for active ingredients, including in-process testing, in accordance with GMP guidelines and internal SOPs. The specialist will also be responsible for verifying batch-related deviations, clarifying observations with relevant departments, and potentially initiating deviation creation. A key aspect of the role is acting as a point of contact for compliance officers in operations and laboratories, contributing to the timely completion of batch documentation, and supporting release preparations. This position is ideal for a detail-oriented professional with a background in biopharmaceutical manufacturing and a strong understanding of quality standards.
Required Skills
Education
Completed training as a Biology or Chemistry Laboratory Technician, CTA, BTA, or other relevant training, ideally with knowledge in biopharmaceutical active ingredient manufacturing
Experience
- Professional experience in Batch Record Review (desirable)
- Experience with GMP and understanding of biopharmaceutical production processes (beneficial)
Languages
Additional
- Not specified
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