Qualified Person TRD

Act as a Qualified Person for certifying Novartis sponsorship investigational medicinal products that enter the EU/EEA when imported from a third country. Operate according to the local law (Article 52 of the Legislative Decree n. 219 of April 24th 2006 from EU directive 2001/83/CE and following modifications; Article 13.3(b) of Directive 2001/20/EC), with respect to the quality of the medicinal products, assurance of compliance to the National Medicines Law and other applicable regulations (e.g. EU GMP Annex 13, 16 and 21).
As Quality Assurance, it is required to support all GMP relevant tasks/issues (operational and strategic) by ensuring compliance according to the internal quality standards, relevant regulatory requirements, filed product quality standards and SOPs in place.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Guarantee and certify that each batch of imported investigational medicinal product is produced and checked by the Third Party extra EU/EEA in compliance with the local and international regulations and the conditions imposed by the IMPD/IND.
• Ensure that all necessary steps have been completed under accepted pharmaceutical quality systems to assure compliance of the batch with GMP, the IMPD/IND, the MA and any other legal obligations in the Member State where certification is taking place;
• Assessment and release of imported investigational 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;
• Evaluation of deviation investigations (related to manufacture, quality control / transport / duty of care check - document review / regulatory file compliance check / storage);
• Support regulatory inspections regarding the imported investigational medicinal product/s to ensure a satisfactory outcome for the site and business, by implementing the operations required by the inspectors;
• Interface with the managers of the various CMO functions for the assessment and resolution of any anomalies/deviations that may occur;
• Collaborate with the Function Managers to guarantee the correctness of the Quality Management System.

What you’ll bring to the role:
• Scientific Degree (CTF, Pharmacy, Chemical Sciences).
• Previous experience in a similar role.
• Ministerial Qualification as a Qualified Person released by AIFA.
• Fluent in English and Italian.
• Project management experience.
Work location: Colleretto Giacosa (TO).
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network