Specialist, Pharmaceutical Batch Record Review | Specialist Batch Record Review - Pharma (m/w/d)

Job Summary

This role involves ensuring strict quality and regulatory compliance by meticulously reviewing batch manufacturing documentation for biopharmaceutical active ingredients, adhering to GMP guidelines and internal SOPs. Key daily tasks include verifying in-process testing results, reviewing batch-related deviations, clarifying observations with technical departments, and initiating deviation creation when necessary. The specialist will also maintain and update relevant checklists, coordinate the timely completion of batch documentation according to the release schedule, and serve as a crucial contact point for compliance officers in production and laboratory environments. This position requires a background in laboratory science or equivalent, strong organizational skills, and established experience with GMP and biopharma production processes, offering the opportunity to directly support product release readiness.