Specialist, Manufacturing Deviation Management | Specialist Abweichungsmanagement Manufacturing (m/w/d) - Penzberg

Job Summary

This role involves joining the Quality Event Management (QEM) team within Pharma Manufacturing in Penzberg, focusing on the production of drug substances in a highly regulated GMP environment. The specialist will independently manage various deviations arising from drug substance manufacturing, guiding them from initial problem description through thorough root cause analysis to the definition of appropriate corrective actions. Key responsibilities include coordinating deviation processing, performing risk classifications, and ensuring GMP-compliant documentation. The position is attractive as it offers the chance to actively drive continuous process improvement using Lean methodologies like Problem Solving and Kaizens, and requires the ability to confidently moderate expert teams and present deviation findings, including in English, during regulatory and internal audits. Candidates need a technical or scientific background and foundational experience in project and time management.