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

Job Summary

This role involves ensuring the quality and compliance of pharmaceutical batch documentation according to strict Good Manufacturing Practice (GMP) guidelines. The Specialist will be responsible for reviewing and processing batch documentation, controlling manufacturing instructions (HABs), and coordinating timely corrections with operational departments. Key tasks include supporting GMP audits and inspections, creating and revising documentation-relevant Standard Operating Procedures (SOPs), and conducting necessary training. A crucial element of the role is the electronic capture, analysis, and evaluation of batch data to identify optimization potential, coordinating cross-functionally to reduce backlogs, and actively participating in the introduction of new Electronic Batch Record (EBR) systems. Candidates must possess strong knowledge of GMP regulations, expertise in MES and SAP systems, and excellent communication skills to drive continuous process improvement within a highly regulated environment.