Head of Quality (Qualified Person)

Responsibilities

• Ensure the maintenance of the plant's production authorization, verifying and ensuring that production activities are carried out in compliance with industry regulations.
• Review and update documentation relating to production and related activities.
• Verification of the performance of stability studies in accordance with ICH guidelines and specific requests.
• Support for development plans, in particular on the possibility and methods of introducing new products and new technologies in order to ensure full compliance with regulatory compliance, the necessary authorizations and legal provisions.
• Care for the professional development of its collaborators also for the purpose of evaluating their performance by providing indications for recognition within the company's merit policies.
• Care and maintain the collaboration between the company departments (Quality, Production, Supply Chain, Warehouse).
• Management of interactions with the Ministry of Health/Italian Medicines Agency (AIFA), for the management of issues within their jurisdiction by actively collaborating in the inspection activities conducted by them.

Qualifications

• 10 to 15 Years of relevant experience.
• Education: Degree in scientific disciplines (Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry, Industrial Chemistry, Biological Sciences, Medicine and Surgery, Veterinary Medicine).

Required Skills

• Professional experience: solid experience in the role gained at companies operating in the chemical-pharmaceutical sector.
• Technical skills: qualification to practice the profession and Registration in the professional register; suitability for the role of Qualified Person issued by AIFA (art. 52 Legislative Decree 24 April 2006 n. 219); solid experience in the management of the Quality Pharma system and good knowledge of GMP standards.
• Language skills: good knowledge of English (oral and written).
• IT skills: advanced use of the MS Office package.