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

Job Summary

This Quality Assurance Engineer role focuses on ensuring the highest production standards within the pharmaceutical industry, specifically through rigorous Batch Record Review and GMP compliance. The successful candidate will be pivotal in controlling and approving manufacturing instructions, managing batch documentation timelines (OLT), and preparing for critical GMP audits. A significant part of the role involves creating and updating Standard Operating Procedures (SOPs), training staff, and analyzing electronic production data to drive continuous improvement. Furthermore, the engineer will contribute to the implementation of new Electronic Batch Record (EBR) systems. Applicants must hold a degree in Biotechnology or a related field, possess professional experience in pharmaceutical production—ideally in Parenterals manufacturing—and demonstrate excellent command of GMP regulations, hygienic standards, and documentation practices. Proficiency in MES, SAP, and MS Office is also required, alongside strong organizational and communication skills. The position offers an attractive, permanent full-time contract and a key role in product and process optimization.