À propos de Jean-Nicolas
Pharmacist specialised in Medical Devices with over 4 years of experience in regulatory affairs and quality. I am recognized for my reliability in post-market monitoring: complaints, CAPA, NC, risk management and audits.
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Accepte de travailler sur site
Lille (jusqu’à 50 km), Marseille (jusqu’à 50 km), Lyon (jusqu’à 50 km), Strasbourg (jusqu’à 50 km), Nice (jusqu’à 50 km)
Expériences
- TALAM - Food supplementsFreelance QARAaoût 2024 - juin 2025 (10 mois)QMS implementation Ensure GMP compliance Realize pharmacopoeia quality analysis Suppliers control Labeling activities Financiel Strategy Development of a fermentation process
- Cristalens - Intraocular M.D.Post Market Surveillance Coordinatoroctobre 2022 - août 2024 (1 an et 10 mois)23 months - October 2022 to August 2024Coordinator of PMS system: Quality, clinical and regulatory organisation Structuring the PMS activity from data collection to data analysis Drafting PMS procedure, plans, reports and PSUR for Intraocular lenses and calculator software Risk management support PMS compliance for international export registrations Design and conduct with the sales team of a surgeon survey
- Cristalens - Intraocular M.D. Class IIBPost Market Surveillance Coordinatoroctobre 2022 - août 2024 (1 an et 10 mois)23 months - October 2022 to August 2024Coordinator of PMS system: Quality, clinical and R&D departments organisation.Structuring the PMS activity from claims, CAPA, NC collection to analysis.Ensure GMP compliance: quality control, process validation, product stability, storage.Drafting PMS procedure, plans, reports and PSUR for Intraocular lenses and calculator software.Risk management supportPMS compliance for international export registrationsDesign and conduct with the sales team of a surgeon survey
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Formations
- Doctor of PharmacyInstitute of Pharmacological and Biological Sciences2021Doctor of Pharmacy - Pharm D
- Biomedical EngineerPolytech Lyon Engineering SchoolBiomedical Engineer
Compétences (9)
Catégories
- Autre