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

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, strictly adhering to GMP guidelines and internal SOPs. Key responsibilities include managing batch-related deviations, resolving observations within the Batch Record documentation in collaboration with specialized departments, and potentially initiating deviation creation. The specialist acts as a central point of contact for compliance officers in production and laboratory settings and assists with coordinating the timely completion of batch documentation according to the release schedule. Candidates should possess relevant technical training (e.g., Biology/Chemistry Laboratory Technician, CTA, BTA), ideally with knowledge of biopharmaceutical active ingredient manufacturing, proven GMP experience, and proficiency in relevant systems like BioMES, SAPLabware, or Idea for Con. Success in this role requires a precise, conscientious, and deadline-oriented work ethic, along with strong communication skills.