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- Responsabilité pharmaceutique du site - garant de la qualité des opérations pharmaceutiques conformément aux exigences des Bonnes Pratiques de Distribution (contrôle des opérations pharmaceutiques, la gestion des rappels et retraits, le traitement des réclamations clients, la gestion de l'exactitude et la qualité des enregistrements, …)- Pilotage des Approvisionnements au sein de l’établissement (collection de produits, commandes fournisseurs, optimisation des stocks, retards de… Show more - Responsabilité pharmaceutique du site - garant de la qualité des opérations pharmaceutiques conformément aux exigences des Bonnes Pratiques de Distribution (contrôle des opérations pharmaceutiques, la gestion des rappels et retraits, le traitement des réclamations clients, la gestion de l'exactitude et la qualité des enregistrements, …)- Pilotage des Approvisionnements au sein de l’établissement (collection de produits, commandes fournisseurs, optimisation des stocks, retards de commandes, alertes ruptures, ...)- Support client et animation de l’équipe de téléphonie. - Participation à l’amélioration des processus et des procédures pharmaceutiques Show less

- Local Business Owner LIMS: software validation review / performance improvement / standardization of processes between sites- Ressources planning for QC department (50 people)- Documentation and quality support: management of non conformities / CAPA / Change control

- Review and batch release of finished products (drugs and cosmetics)- Manage and promote continuous improvements process (non conformity, CAPA and change management)- Quality support: involvement with operational staff to provide a global vision to assess risk and impact

- Support and improve quality system management in compliance with applicable requirement (ISO 9001, ISO 13485, QSR 21 CFR 820)- Implement the new corporate standards following the acquisition of Allergen- Manage the internal audits and coordinate third parts inspection- Promote quality system in the company

Response to the FDA Form 483 about change management of references standards and critical reagents in QC Laboratories:- Implementation of a traceability system of changes - Definition of reporting decision of changes with regulatory affairs and transposition in QC Lab- Evaluation of reporting level for each reagents change - Training of impacted employees

- Qualification improvement of biological references standards in QC lab- Definition of a strategy for the monitoring of internal reference standards

- Participation to internal audits and the new organization of the logistic department in the context of release of immunological products (ISO 17025) at the Direction of Laboratories and Controls

- Manufacturing of sterile products- Physicochemical analyses and control of particles and endotoxins

Determination of phenylalanine by fluorimetric technique on blood spots deposited on blotting paper in the context of neonatal screening and monitoring of phenylketonuria patients-> Thesis: Validation of phenylalanine assay method for accreditation of medical biology laboratories according to standard ISO 15189:2012