Logistics Operations Manager Italy

Purpose of the position and responsibilities:
Individuals eligible to hold the role of Qualified Person must have obtained official recognition of suitability from the Italian Medicines Agency (AIFA) to perform this function (Article 52, paragraph 3, Legislative Decree 219/2006).
The Qualified Person (QP) ensures that all operational activities related to secondary packaging and quarantine areas comply with GMP guidelines, regulatory requirements, and the company’s main Quality policies.

Specific duties:

• Is responsible for the implementation and compliance with GMP in relation to processes authorized by AIFA;
• Ensures that the release of products for distribution is carried out in accordance with defined requirements;
• Ensures compliance with the defined and approved procedures for reworking/inspection activities of finished products;
• Actively collaborates with inspections conducted by the health authorities;
• Oversees the general hygiene conditions of the premises under their responsibility;
• Ensures personnel training in accordance with GMP requirements;
• Ensures the implementation and ongoing compliance with GMP.