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Qualified Person

REQ-10044134
3月 13, 2025
Italy

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? http://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: http://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: http://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? http://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: http://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

Operations
Innovative Medicines
Italy
Ivrea
Quality
Full time
Regolare
No
A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10044134

Qualified Person

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Source URL: http://www.wmsdly.com/careers/career-search/job/details/req-10044134-qualified-person-it-it

List of links present in page
  1. http://www.novartis.com/about/strategy/people-and-culture
  2. http://talentnetwork.novartis.com/network
  3. http://www.novartis.com/careers/benefits-rewards
  4. http://www.novartis.com/about/strategy/people-and-culture
  5. http://talentnetwork.novartis.com/network
  6. http://www.novartis.com/careers/benefits-rewards
  7. http://novartis.wd3.myworkdayjobs.com/it-IT/Novartis_Careers/job/Ivrea/Qualified-Person_REQ-10044134-1
  8. http://novartis.wd3.myworkdayjobs.com/it-IT/Novartis_Careers/job/Ivrea/Qualified-Person_REQ-10044134-1