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

Job Summary

This role is ideal for a compliance-focused professional seeking continuous development within the pharmaceutical industry. As a Batch Record Specialist, you will be responsible for ensuring the integrity and compliance of manufacturing documentation, primarily by reviewing and processing batch records in strict adherence to GMP guidelines and Order Lead Time requirements. Day-to-day tasks include controlling manufacturing instructions, coordinating timely corrections with operational departments, and supporting crucial GMP audits and inspections. A key component of the role involves documentation management, including creating and revising Standard Operating Procedures (SOPs) and conducting necessary training sessions. Furthermore, you will utilize electronic systems (MES, SAP) to capture, evaluate, and analyze batch data, identifying areas for process optimization and improvement. The position requires a completed degree in Biotechnology or a related field (or equivalent vocational experience), expert knowledge of GMP and pharmaceutical hygiene standards, and proficiency in German (Fluent) and English (Intermediate). You will also play a part in implementing new Electronic Batch Record (EBR) systems, making this an impactful role in process modernization.