Qualified person

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7et7v4

Location Colleretto Giacosa (Ivrea), Italy. This role is based in Ivrea, Italy. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Position Overview We are seeking a highly qualified and independent Qualified Person to oversee and ensure the compliance of manufacturing and quality control activities at the site, in accordance with the applicable drug manufacturing license and local regulatory requirements. In this role, the Qualified Person will independently supervise manufacturing processes and control testing activities, acting in full compliance with Article 52 of Legislative Decree No. 219 of April 24, 2006, derived from EU Directive 2001/83/EC, and subsequent amendments. The role is critical in ensuring that medicinal products meet the required standards of quality, safety, and regulatory compliance. Major Accountabilities Certify and release medicinal product batches, ensuring manufacturing and testing are performed in compliance with applicable laws, GMP requirements, and Marketing Authorization conditions.



Ensure batch documentation and records are complete, accurate, properly stored, and available for inspection or upon request by Health Authorities. Assess and release manufactured medicinal products in accordance with national legislation and Qualified Person responsibilities. Collaborate with Quality Control and Production teams to support batch‐related activities and ensure smooth, compliant production operations. Review, support, and approve quality processes including deviations, complaints, change controls, CAPAs, and related investigations. Immediately elevate any significant quality irregularities identified in marketed products to site management and the Italian Medicines Agency, AIFA, as required. Partner with functional leaders to maintain, monitor, and continuously improve an effective GMP‐compliant Quality Management System. Identify and propose technological, procedural, and

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7et7v4