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

Job Summary

This role as a Quality Assurance Engineer specializing in Batch Record Review is central to maintaining the highest production standards within the pharmaceutical industry. You will be responsible for ensuring strict adherence to Good Manufacturing Practice (GMP) regulations through meticulous documentation control, including the review and approval of Manufacturing Instructions and rebookings. A core daily task involves managing batch compliance, tracking Order Lead Time (OLT), and preparing comprehensive support documents. Furthermore, you will actively support GMP audits, develop and revise Standard Operating Procedures (SOPs), and conduct internal staff training. The position requires strong analytical skills for the electronic capture and evaluation of production data to identify improvement potential, alongside participation in the implementation of new Electronic Batch Record (EBR) systems. Candidates must hold a degree in Biotechnology or a related field, possess professional experience in pharmaceutical production (ideally Parenteralia), and demonstrate fluency in both German and English.