Senior QA Operations Expert; Qualified Person (m/f/d)

Job description

Band Level 5 Job Description Summary: #LI-Hybrid Location: Schaftenau, Austria: The Qualified Person (QP / Sachkundige Person) is responsible for the final certification and release of medicinal products in accordance with § 7 of the Arzneimittelbetriebsordnung (AMBO 2009). Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act (AMG), the Marketing Authorization, and current GMP requirements. With clear legal accountability, you will verify product quality and documentation to ensure no batch is released—whether for the Austrian market or for export—without confirmed compliance. Job Description: Key responsibilities: ​: Technical Release and Market Release (Certification) of secondary packed drug product batches (FDF batches) for commercial purposes. Tasks of a Qualified Person in accordance to the “Arzneimittelbetriebsordnung (AMBO) 2009” and Annex 16 to Volume 4 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human Use. Lead and oversee critical negotiations with internal and external stakeholders to secure compliant, timely outcomes. Provide people leadership (coaching, perf...