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 of deviations, complaints, change control and CAPA.

Essential requirements:

• Degree in Pharmacy, CTF or Chemistry.
• Previous experience in the role within a pharmaceutical sterile 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.

This role is 100% site based in Ivrea.