Senior Quality Assurance Specialist
4 settimane fa
As a Senior Quality Assurance Specialist at Chiesi Group, you will be responsible for managing products and projects related to the respiratory area from a qualitative and analytical perspective. You will collaborate with other functions locally and at the Corporate level, interfacing with R&D, regulatory functions, and external consultants. Your key responsibilities will include implementing guidelines for system and process validation activities in compliance with national and international GMP regulations, supervising validation activities at Chiesi sites, and managing change control and deviations related to Corporate products and processes.
Experience RequiredYou will require at least 6-8 years of experience in Quality Assurance in the pharmaceutical industry. A degree in Chemistry, Industrial Chemistry, CTF, Biotechnology, Biology, or equivalent is also required. Fluency in English is essential, and knowledge of French will be considered a plus.
Technical SkillsYou will need excellent knowledge of international pharmaceutical legislation, including CFR tit21 and European directives, as well as international regulatory references such as FDA, EMEA, and ICH. You should also have knowledge of Total Quality Management standards and principles, management information systems (ERP), and suppliers and subcontractors in the Italian and European sphere.
Soft Skills- Proactiveness
- Adaptability and flexibility
- Communication skills
- Quality orientation
At Chiesi Group, we believe that our people are our most valuable asset. We invest in continuous training, learning, and development, and strive to promote and satisfy development needs while paying attention to the quality of our working environment and collective well-being. We offer flexible working approaches, remote working, support in the relocation process, tax assistance services for foreign colleagues, and many other people-care services.
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