Quality Assurance Engineer – Batch Record Review | Ingenieur (m/w/d) Qualitätssicherung – Batch Record Review (1604)

Job Summary

This critical role places you at the center of ensuring the highest production standards within the pharmaceutical industry, focusing specifically on GMP-compliant documentation and batch review processes. Day-to-day responsibilities include the rigorous control and approval of manufacturing instructions and rebookings, managing batch documentation to meet Order Lead Time (OLT) requirements, and actively supporting GMP audits. You will be instrumental in maintaining regulatory adherence, creating and adjusting Standard Operating Procedures (SOPs), and conducting internal staff training. Furthermore, the position involves analyzing production data to identify areas for improvement and participating in the implementation of new Electronic Batch Record (EBR) systems. The ideal candidate holds a degree in Biotechnology or a comparable field, brings professional experience in pharmaceutical production (preferably Parenterals manufacturing), and possesses strong knowledge of GMP regulations and documentation practices. This is a permanent, full-time position offering attractive compensation and a key role in product and process optimization.