Batch Record Specialist | Specialist Batch Record (w/m/d)

Job Summary

This role requires a dedicated professional to manage the review and processing of batch documentation, ensuring stringent adherence to Good Manufacturing Practice (GMP) guidelines and maintaining the Order Lead Time. Day-to-day tasks involve controlling manufacturing instructions, coordinating timely corrections with operational departments, and actively supporting GMP audits and regulatory inspections. The specialist will be responsible for creating and revising documentation-relevant Standard Operating Procedures (SOPs), conducting necessary staff training, and electronically capturing and analyzing batch data to identify optimization potential. A key focus is cross-functional coordination to reduce backlogs and drive sustainable process improvements. The ideal candidate holds a degree in Biotechnology or a related field, possesses excellent knowledge of GMP, MES, and SAP systems, and demonstrates strong communication skills and a high sense of responsibility. This position offers a chance to significantly contribute to compliance and process efficiency within the pharmaceutical sector, including involvement in implementing new Electronic Batch Record (EBR) systems.