Qualified Person

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.