Qualified Person

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Summary#LI-OnsiteLocation: Colleretto Giacosa (Ivrea), ItalyThis 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.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.Working closely with the Site Quality Head and Site Manager, the successful candidate will support the effective implementation, monitoring, and continuous maintenance of a GMP-compliant Quality Management System.



This includes ensuring adherence to national medicines legislation, applicable regulations, internal ADACAP quality standards, approved product quality requirements, and site SOPs.As part of the Quality Assurance function, the role will provide both operational and strategic support for GMP-related activities, helping to identify, manage, and resolve quality issues while promoting a culture of compliance, accountability, and continuous improvement across the site.About the RoleMajor 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 accordanc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fct6e