Validation-Qualification Officer in the pharmaceutical industry (M/F)
CHIESI is an Italian family-owned pharmaceutical group offering innovative therapeutic solutions to patients in three areas of expertise: AIR (products and solutions for respiratory diseases from newborn to adult), RARE (treatments for rare and ultra-rare diseases), CARE (products and services in kidney and liver transplantation) and prevention (micronutrition). Grouping nearly 6500 employees worldwide, CHIESI is present in France across the entire value chain - R&D, production, distribution and provision to healthcare professionals and patients. Certified B-Corp, CHIESI is committed to improving the quality of life of patients, in a responsible and sustainable manner towards society and the environment. Since April 2021, CHIESI France has been the first pharmaceutical laboratory to be a "Société à Mission" (Benefit Corporation). For more information, access the site here: www.chiesi.fr
In France, the subsidiary has approximately 600 employees, including 300 at its industrial site in the centre region (41260 La Chaussée Saint Victor). If you wish to join a company teeming with projects (site extension, new industrial line, etc.) and strongly committed to reducing its environmental impact, the well-being of patients, as well as that of its employees, then the values of this company and this position are made for you!
Reporting to the Quality Assurance Validation and Changes Manager, the Quality Assurance Validation and Changes Officer's main missions are to:
Guarantee the compliance of the site's qualification and validation activities according to GMP. Guarantee data integrity and the compliance of computerized systems. Lead and monitor the change management process (Change Control). Ensure quality risk management for the site's pharmaceutical activities. Participate in the preparation of regulatory audits and inspections and ensure the follow-up of associated action plans. Contribute to the Health, Safety, Environment and Energy (HSEE) management system.
Profile sought: Master's degree (Bac+5) in pharmacy, quality, engineering or equivalent, with a minimum of 3 to 5 years of experience in pharmaceutical Quality Assurance, ideally in an environment subject to regulatory inspections (ANSM, FDA, ANVISA.).
Key skills: mastery of GMP/BPF, GDP/BPD, ICH frameworks, English, analytical capacity and transversal teamwork. Organization, rigor, communication, critical thinking and being proactive are also expected.
Join us at CHIESI and actively contribute to guaranteeing the quality and compliance of our pharmaceutical activities, at the heart of the validation and change control challenges of our industrial site.