摘要
Responsabile della gestione degli aspetti qualitativi all'interno dell'area di responsabilità e di garantire che l'attività operativa sia conforme alle cGMP (Current Good Manufacturing Practices), all'Accordo di Garanzia della Qualità, ai requisiti normativi e al Manuale di Qualità Novartis e sia condotta secondo le relative Procedure Operative Standard
About the Role
Major accountabilities:
- Guarantee and certify that each batch of medicines is produced and checked in compliance with the law and the conditions imposed in the marketing authorization.
- Assessment and release of manufactured medicinal products, in accordance with national legislation.
- Guarantee that the documentation attesting the suitability of each product lot is available and can be shown at the request of the health authority.
- Collaborate in the approval of deviation investigations.
- Make sure that the batch record of the released batch is stored correctly and can be exhibited at the request of the health authority.
- Communicate immediately to the national Health Authority (AIFA) and to the Management any substantial irregularity detected in the product that has already been placed on the market.
- Work in collaboration with Quality Control and Production departments in the activities related to the manufactured batches.
- Identify and propose technological and organizational interventions aimed at improving manufacturing processes in terms of quality, productivity and costs and the optimization of resources.
- Collaborate with the Function Managers in order to guarantee the correctness of the Quality Management System.
- Management od deviations, complaints, change control and CAPA.
Essential requirements:
- Degree in Pharmacy, CTF or Chemistry.
- Previous experience in the role within a pharmaceutical manufacturing environment (Authorized Qualified Person certificate according to Legislative Decree n. 219 of April 24th, 2006).
- Strong affinity with quality and awareness of quality issues.
- Open and clear collaboration and communication to make sure the daily production operation runs smoothly and safely.
- 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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Innovative Medicines
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl
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