摘要
Supports the preparation and management of external and corporate audits and Health Authority inspections.
About the Role
Major accountabilities:
- Planning and supporting PQR/APQR activities.
- Support site qualification and validation activities (planning, advising, review).
- Implementation of Quality Systems (incl. documentation management).
- Supplier management activities (agreements, oversight, audit).
- Preparation/support and coordination of CAPA/follow-up.
- Audit and inspection preparation and support.
- Change control review/approval.
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.).
- Ensure process quality assurance according to regulations.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Minimum Requirements:
- Scientific degree.
- Previous experience in a Quality Assurance department within a pharma manufacturing environment.
- People management skills.
- Fluent in Italian and English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
