Batch Records Review Specialist | Referent Batch Records Review (w/m/d)

Job Summary

This role involves ensuring the integrity and compliance of pharmaceutical manufacturing documentation by serving as a Batch Records Review Specialist. Day-to-day responsibilities include the meticulous review and evaluation of batch documentation and associated records, strictly adhering to Good Manufacturing Practice (GMP) guidelines and meeting order lead times. The specialist will guarantee correct and complete documentation, track corrections, and request necessary supporting documents from relevant departments. A key function is the analysis of batch and process data to identify trends, error sources, and optimization potential, providing feedback to operational units. Furthermore, the role requires active participation in internal and external audits and inspections, including the preparation and presentation of batch records. Candidates must possess a degree in a natural science or technical field (e.g., Pharmacy, Biology, Engineering) and several years of practical experience in a GMP-regulated production environment, particularly with complex products like sterile or biological pharmaceuticals.