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

Job Summary

This role involves ensuring the quality and compliance of pharmaceutical production documentation by performing thorough reviews of batch records for finished medicinal products, bulk goods, and intermediate products. The specialist will operate strictly according to legal frameworks such as the German Medicines Act (AMG), the German Medicinal Products Manufacturing Ordinance (AMWHV), and Good Manufacturing Practice (GMP) guidelines, alongside internal specifications. Key daily tasks include processing and evaluating deviations identified during bulk production and packaging, ensuring all activities are documented correctly and in compliance with GMP standards, and reporting/tracking deviations in Standard Operating Procedures (SOPs) or batch documentation. This position is ideal for professionals seeking a dynamic environment within the growing pharmaceutical industry, offering opportunities for personal and professional development through varied tasks and continuous training.