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
Cgmp and gxp requirements
Novartis is seeking a Senior QA Operations Expert and Qualified Person in Schaftenau, Austria, responsible for the certification and release of medicinal products in compliance with Austrian regulations. The role requires strong leadership, collaboration, and technical skills in quality assurance and 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.
In accordance with Austrian law, the minimum salary is € 73.122,90/year.
Matching Summary
Match Score: 85
Novartis is seeking a Senior QA Operations Expert and Qualified Person in Schaftenau, Austria, responsible for the certification and release of medicinal products in compliance with Austrian regulations. The role requires strong leadership, collaboration, and technical skills in quality assurance and 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
cGMP and GxP requirements
Quality Management System processes
technical complaints, adverse events reporting
inspection and audit readiness
people leadership and coaching
Nice-to-have
continuous improvement focus
patient-focused environment
navigating ambiguity effectively
digital proficiency
Key Requirements
Proven experience in Audit and Inspection Management