Expertise fonctionnelle M.E.S, PMX WES, Warehouse management system, dispensing, pes茅e.
Expertise Validation des syst猫mes informatis茅s,21 CFR part 11, GMP EU annex 11, GxP/BPF, GAMP5, PIC/S, Analyses de risques, R茅daction SBU, Change control, sur LIMS, monitoring des contaminations environnementales, syst猫me de gestion des incidents et d茅viations, ERP Module Qualit茅/Finance, WES, Manufacturing execution system Packaging.
Mise en place des strat茅gies de validation, plan/rapports, protocoles QI/QO/QP et fiches de test
Gestion du changement sur 茅quipements (Remplissage, formulation, mirage), HVAC, Utilit茅s (analyses d'impact, plans d'implementation, suivi des r茅alisations des act
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