GMP Support Specialist with Focus on Documentation and Complaint Management | Fachkraft (m/w/d) GMP-Support mit Schwerpunkt Dokumentations-/Reklamationsmanagement

Job Summary

This role is for a dedicated GMP Support Specialist focusing on documentation and complaint management within a production environment for an innovative pharmaceutical company. The specialist will be responsible for managing internal packaging complaint processes, including suspected counterfeiting cases, and supporting deviation management. A key part of the role involves creating, maintaining, and optimizing Standard Operating Procedures (SOPs) and training concepts to ensure compliance with GMP and EHS guidelines. The position also requires translating overarching standards into practical departmental processes, contributing to qualification and validation activities for packaging equipment and processes, and conducting change control procedures and risk analyses. The ideal candidate will possess strong analytical skills, a high degree of quality awareness, and excellent communication abilities to collaborate effectively across interdisciplinary teams, ensuring regulatory requirements are met.