Batch Production Record Review Specialist, Manufacturing Operations | BPRR Specialist MFG Ops

Job Summary

This specialist role focuses on ensuring GMP-compliant documentation for manufacturing processes within the Penzberg production site, acting as a critical link between operations and quality assurance. Day-to-day responsibilities include independently preparing, conducting, and finalizing Batch Production Record Reviews (BPRR) using systems like Pirol and SAP, verifying adherence to manufacturing parameters, and processing GMP-relevant documents. The role involves actively managing deviations, preparing batch records for internal and external inspections, and representing documentation content to auditors. A key aspect is contributing to the continuous improvement of the BPRR process to enhance efficiency and reduce cycle times. The ideal candidate brings professional experience in pharmaceutical production or quality assurance within a GMP environment, strong IT affinity, and excellent communication skills in both German and English.