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

Aug 25, 2021

Job Description

(Senior) QA Operations Expert / Qualified Person (f/m/d), STO Anti-Infectives FDF / Steriles, Kundl, Austria

120 Million! This is the number of sterile vials that we produce in FDF Kundl and deliver to patients in more than 80 countries all over the world in a year! As QA Operations Expert / Qualified Person, you will be taking on a highly responsible role through securing that all our sterile products adhere to the highest GMP standards. Hereby you ensure that our patients receive the high-quality medicine which improves and extends their lives. Apply now to become a part of our dynamic team!

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Support of the Quality Assurance team within the production area
• Batch Record Review for the final release of products
• Evaluation and processing of complaints, deviations, OOS and change control
• Creation and improvement of quality systems and SOPs
• Review of manufacturing guidelines, testing methods and specifications
• Conduction of risk analyses and product quality reviews, involvement in qualification and validation processes
• Creation, testing and approval of quality-relevant documentation
• Preparation, participation in and follow-up of self-inspections, customer audits and authority inspections

Minimum Requirements

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Novartis Technical Operations
Full Time

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

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