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

Job Summary

This Quality Assurance Engineer role is central to ensuring the highest production standards in the pharmaceutical industry, focusing heavily on GMP-compliant documentation and batch review. Day-to-day responsibilities include controlling and approving manufacturing instructions (HABs), managing batch records, and ensuring strict adherence to the Order Lead Time (OLT). The engineer will actively support GMP audits, process regulatory measures, and play a key role in developing and updating Standard Operating Procedures (SOPs), while also conducting internal employee training. A critical technical component involves the electronic capture and evaluation of production data to identify process improvement potential, including participation in the implementation of new Electronic Batch Record (EBR) systems. Candidates must hold a degree in Biotechnology or a comparable technical field, possess professional experience in pharmaceutical production (ideally Parenteralia manufacturing), and demonstrate strong proficiency in GMP regulations, MES, SAP, and MS Office. This is a permanent, full-time position offering a key role in quality assurance with direct influence on product and process optimization.