Batch Record Review Specialist | Spezialist Batch Record Review (w/m/d)

Job Summary

This role involves ensuring pharmaceutical quality and regulatory compliance by focusing on the meticulous review of batch records for finished medicinal products, bulk goods, and intermediate products. The specialist will be responsible for reviewing documentation according to the German Medicines Act (AMG), the Ordinance on the Manufacturing of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV), Good Manufacturing Practice (GMP), and internal specifications. Day-to-day tasks include processing and evaluating deviations found during bulk production and packaging, ensuring all activities are properly and GMP-compliant documented, and reporting/tracking deviations in Standard Operating Procedures (SOPs) or batch documentation. Key requirements include a pharmaceutical, chemical, or biological background, professional experience in the pharmaceutical industry, and deep knowledge of relevant quality processes and regulations. The position offers a permanent contract, excellent support for professional development, and opportunities to work in a growing, varied environment.