Senior Qa Operations Expert; Qualified Person (m/f/d)
Novartis
Schaftenau, Austria
Base: € 73.122,90pyear; bonus/equity: not specifie...
On-site
Final certification and release of medicinal products
Compliance with austrian medicines act
Gmp requirements
Novartis is seeking a Senior QA Operations Expert and Qualified Person in Schaftenau, Austria, responsible for ensuring the compliance and certification of medicinal products. The role includes overseeing audit readiness, leading quality management initiatives, and ensuring adherence to Good Manufacturing Practices (GMP)
Job Summary
The Qualified Person is responsible for the final certification and release of medicinal products in accordance with § 7 of the Arzneimittelbetriebsordnung (AMBO 2009).
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.
The minimum salary for this position is € 73.122,90/year (on a full-time basis).
Matching Summary
Match Score: 85
Novartis is seeking a Senior QA Operations Expert and Qualified Person in Schaftenau, Austria, responsible for ensuring the compliance and certification of medicinal products. The role includes overseeing audit readiness, leading quality management initiatives, and ensuring adherence to Good Manufacturing Practices (GMP).
Salary
Base: € 73.122,90/year; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
final certification and release of medicinal products
compliance with Austrian Medicines Act
GMP requirements
Quality Management System processes
cGMP and GxP requirements
Nice-to-have
people leadership and capability building
collaboration across functions and boundaries
inspection and audit readiness
Key Requirements
Proven experience in Audit and Inspection Management