QC Operations Manager

vor 10 Stunden

Kundl, Tirol, Österreich Novartis Vollzeit

Key Responsibilities:

Oversight of production and testing activities to ensure compliance with cGxP standards, including data integrity and electronic compliance.

Major Accountabilities:

  • Participation in validation preparations, transfers, protocols, and reports; approval of specifications, instructions, testing methods, and Production Master Batch Records.
  • Elaboration and approval of investigations on deviations, out-of-specifications, and complaints; evaluation and approval of corrective actions and risk assessments.
  • Execution of batch releases in accordance with cGxP standards and registration.
  • Participation in process and specification changes; collaboration in or management of project teams.
  • Preparation and participation in audits and inspections; participation in and approval of quality agreements.
  • Responsibility for release; support operational excellence improvement projects.
  • Reporting of technical complaints and adverse events within 24 hours.

Requirements:

  • University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or equivalent.
  • At least 3 years of experience in QC or QA or medical device industry.
  • Experience in operations management and execution; preferably in negotiations and global collaboration.
  • Fluent knowledge of English and German language (written and spoken).
  • Flexibility to work in a fast-paced environment; ability to operate in a global matrix environment.

Why Novartis?

We aim to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. Our people drive us to reach our ambitions. Be part of this mission and join us at Novartis.

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