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QA Operations Specialist I (m/f/d)



Operations, Quality Assurance
Posted on Thursday, November 16, 2023

About the Role

Location: Ljubljana, #LI-Hybrid

Join a dynamic group of experts or the release of incoming materials as Quality Operations Specialist. You will ensure smooth production of medicines, and consequently timely supply to customers or patients. Your role will involve monitoring the quality of supplied incoming materials and releasing them into production, as well as ensuring the development of an internal quality system in accordance with legislation, internal regulations, best practices, and business objectives. You will collaborate with various departments and a wider group of customers within Novartis worldwide.

Key Responsibilities:
• Ensure all activities are in compliance with cGxP, incl. data integrity.
• Review and approval of analytical data / tests (analytical release).
• Support exception investigations.
• Support Operational Excellence improvement projects.
• Ensure production and laboratory's GxP compliance and execution of activities in accordance with Slovenian, EU laws, Food and Drug Administration (FDA), International Council for Harmonisation Technical Requirements for pharmaceuticals for Human Use (ICH), The Pharmaceutical Inspection Convention (PIC) regulations and Novartis standards (including DI and e-compliance).
• Active participation in global projects, initiatives.
• Participation in deviation and complaint investigations, corrective and preventive actions management.
• Ensuring release of incoming materials in accordance with Slovenian, European Union (EU), Food and Drug Administration (FDA) and local regulations and all company regulations, contracts with partners, and internal procedures.