Specialist Batch Record Review | Specialist* Batch Record Review - Roche Mannheim

Job Summary

This role involves ensuring strict Good Manufacturing Practice (GMP) compliance by meticulously reviewing batch records and associated documentation for a leading diagnostics company in Mannheim. The specialist will conduct operational reviews of batch papers, verify documentation consistency (including HABs and rebookings), and ensure timely adherence to Order Lead Times (OLT). Key responsibilities include tracking and demanding accompanying documents (IPC sheets, Audit Trails, EMT reports), supporting GMP audits and inspections (including in English), and actively contributing to Continuous Improvement Process (CIP) projects. The ideal candidate possesses a Bachelor's degree in a scientific field or equivalent technical qualification, extensive experience in a GMP production environment, and excellent German and fluent English skills, focusing on process optimization and maintaining high documentation standards.