Qualified Person

Independently supervise, without third‑party interference, manufacturing processes and control testing related to the drug manufacturing license, operating as Qualified Person in accordance with Article 52 of Legislative Decree n. 219 of 24 April 2006 (EU directive 2001/83/CE) and subsequent amendments. Ensure compliance with the National Medicines Law and other applicable regulations, and work with the Site Quality Head and Site Manager to maintain an effective GMP‑compliant quality system.

Responsibilities

• 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.
• Assess and release 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 upon request of the health authority.
• Collaborate in the approval of deviation investigations.
• Ensure 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 management any substantial irregularity detected in a product already on the market.
• Work in collaboration with Quality Control and Production departments on activities related to manufactured batches.
• Identify and propose technological and organizational interventions aimed at improving manufacturing processes in terms of quality, productivity, costs and resource optimization.
• Collaborate with Function Managers to guarantee the correctness of the Quality Management System.
• Manage deviations, complaints, change control and CAPA.

Required Qualifications

• Degree in Pharmacy, CTF or Chemistry.
• Previous experience in a pharmaceutical sterile manufacturing environment.
• Certificate as Qualified Person according to Legislative Decree n. 219 of 24 April 2006.
• Strong affinity with quality and awareness of quality issues.
• Open and clear collaboration and communication to ensure the daily production operation runs smoothly and safely.
• Fluent in Italian and English.

This role is 100% site based in Ivrea.