Quality Assurance Specialist / Assistant Qualified Person – GMP / Investigational Medicinal Products | Quality Assurance Specialist / Assistant Qualified Person (m/w/d) – GMP / Prüfarzneimittel

Job Summary

This role involves supporting the Qualified Person (QP) in the procedural and administrative release of Investigational Medicinal Products (IMPs) at the Biberach an der Riß site. Daily responsibilities include the meticulous review of release documentation to ensure complete compliance with regulatory submissions (CTAA), GMP standards, and internal guidelines. The specialist will document and evaluate results, maintain relevant KPIs, and actively contribute to optimizing release processes and systems. Key tasks also involve assisting with Batch Record Review and assessing batch-specific data. Success requires efficient communication and collaboration with both internal and external interfaces to swiftly resolve open issues. This position is ideal for a science professional with a Master's degree or extensive pharmaceutical vocational experience, possessing deep knowledge of national and international regulatory requirements for IMPs and clinical trials, coupled with fluent English skills and a structured, responsible work ethic.