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Quality Assurance Manager

1 settimana fa


Montà, Italia Novartis Italia A tempo pieno
Job Description

The Quality Assurance Manager will report to the QC Head and be responsible for ensuring that Quality Control processes are executed and fully compliant with cGMPs regulation, corporate and national guidelines. The role will involve supporting the QC Head in managing analytical activities for batch release and raw materials acceptance.

Key responsibilities include:

  • Coordinating and approving analytical activities for batch release and raw materials acceptance
  • Ensuring proper storage and management of QC materials, reagents, and standards
  • Investigating and resolving out-of-specification (OOS), out-of-trend (OOT), and system suitability test failures
  • Validating analytical methods according to SOPs, MA, and cGMPs
  • Supporting the development and implementation of stability programs and annual product reviews

Requirements:

  • Scientific degree (CTF, Pharmacy, or Chemistry preferred)
  • Previous experience in a similar role within a GMP lab environment
  • Fluent in Italian and good knowledge of English