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

Job Summary

This Senior Batch Record Specialist role involves ensuring strict compliance with Good Manufacturing Practice (GMP) regulations by reviewing and processing batch documentation, including manufacturing instructions (HABs) and coordinating timely corrections. Key responsibilities include supporting GMP audits and inspections, implementing regulatory requirements, and creating/revising documentation-relevant Standard Operating Procedures (SOPs), alongside conducting necessary training. The specialist will also be responsible for the electronic capture, evaluation, and analysis of batch data to identify optimization potential, coordinating across interfaces to reduce backlogs, and actively participating in the introduction of new Electronic Batch Record (EBR) systems. This position requires a Master's degree in Biotechnology and substantial professional experience in parenteral manufacturing, coupled with expert knowledge of GMP, documentation standards, and proficiency in MES and SAP systems.