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QA Operations Expert

vor 2 Monaten

Langkampfen, Österreich Novartis Pharma GmbH Vollzeit
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Novartis Pharma GmbH. As a key member of our QA Medical Device team, you will play a critical role in supporting the commercialization of new medical devices worldwide.

Key Responsibilities:
  • Oversee all production and testing activities to ensure compliance with cGxP, including data integrity and eCompliance.
  • Support exception investigations and review production, QC, and AS&T records.
  • Manage quality aspects within your area of responsibility and ensure operational business compliance with cGMP, Quality Assurance Agreement, regulatory requirements, and Novartis Quality Manual.
  • Review and approve DHF and DMR documents for Commercial medical devices and combination products.
  • Responsible for third-party management of device component and primary packaging material suppliers.
Essential Requirements:
  • University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or equivalent.
  • At least 3 years of experience in MS&T, QC, or QA or medical device industry.
  • Experience in operations management and execution.
  • Preferably experience in negotiations and global collaboration.
  • Fluent knowledge of English language (written and spoken), German is an advantage.
  • Flexibility to work in a fast-paced, quickly changing work environment.
  • Ability to operate in a global matrix environment.
Why Novartis?

At Novartis, our purpose is to reimagine medicine to improve and extend people's lives. We strive to become the most valued and trusted medicines company in the world. Our associates drive us each day to reach our ambitions, and we are committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.