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

Job Summary

This role involves independently conducting Batch Record Reviews (BRR) within the production environment, focusing on the meticulous examination and evaluation of both electronic and paper-based manufacturing documentation. The specialist will coordinate necessary corrections and supplements in close collaboration with relevant departments and production staff to resolve discrepancies in accordance with strict GMP guidelines. A key part of the role includes acting as a PDOCS expert for document management and system research, supporting the creation of monitoring and GMP reports, and managing projects related to BRR. Candidates must possess a background in pharmaceuticals or chemistry, significant experience in GMP and Batch Record Review, and a precise, structured, and responsible working style, making this a crucial position within a quality-oriented, regulated environment.