Senior Specialist, Batch Record Review | Senior Specialist * Batch Record Review - Roche Mannheim

Job Summary

This Senior Specialist role focuses on critical Batch Record Review processes within Roche Diagnostics in Mannheim, ensuring strict adherence to Good Manufacturing Practice (GMP) standards for parenteral manufacturing. Day-to-day responsibilities include the thorough operational review of batch records (HABs) and associated documentation, verifying GMP-compliant documentation, and ensuring timely corrections, often utilizing Electronic Batch Review systems. The specialist tracks Order Lead Time (OLT), manages accompanying documents like Audit Trails and IPC sheets, and actively supports GMP audits and inspections. A key component is driving process optimization initiatives, collaborating with quality teams to improve documentation practices, and reducing error trends. The ideal candidate holds a Master's degree in Biotechnology or a comparable field, possesses fundamental professional experience in parenteral manufacturing, and demonstrates leadership capabilities. Essential qualifications include deep knowledge of GMP regulations, proficiency with IT systems (MES, SAP, Excel, Word), and strong communication skills in both written and spoken German and English.