Expert Batch Record Documentation Specialist | Experte Chargedokumentation (m/w/d)

Job Summary

This role is for an Expert Batch Record Documentation Specialist in the pharmaceutical industry in Mannheim, focusing on ensuring GMP-compliant documentation for pharmaceutical production. The specialist will be responsible for managing deviations, CAPAs, and process changes, including root cause and impact analysis using systems like Veeva. A key part of the role involves meticulous review of batch records, ensuring adherence to GMP standards, and tracking corrections, often within Electronic Batch Review systems. The position also entails managing deadlines, supporting audits and inspections, creating and revising SOPs, and conducting training on documentation-related topics. Furthermore, the specialist will contribute to process optimization initiatives to enhance documentation practices and support the implementation of new Electronic Batch Record (EBR) systems, coordinating cross-functional batch reviews to reduce backlogs and improve processes.