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Product Quality Manager
vor 3 Wochen
Activités principales
- Gérer l'équipe AQP
- Manager les processus qualité afin de garantir la libération sur le marché des lots conformément aux réglementations en vigueur, de la politique qualité et des procédures Teoxane
- Être responsable du processus de libération des matières premières, articles de conditionnement et des lots de produits finis
- Réaliser la libération des lots en accordance avec les besoins marchés en garantissant la qualité produit et la sécurité patient
- Être responsable du processus de non-conformité
- En tant que QA référent sur les non-conformités, approuver les investigations, statuer sur ces lots concernés et gérer les CAPAs associées
- Être le QA référent des changes control pour les produits commercialisés
- Approuver la documentation qualité en lien avec les activités de production et d'ingénierie et s'assurer de leur bonne application sur le terrain
- Assurer le QA oversight en production / une présence terrain : participer aux réunions de production et aux points d'animation réguliers, réaliser des gembas -.
- Être le QA référent des projets d'amélioration de la production
- Assurer le pilotage des indicateurs de performance de gestion des activités, notamment le RFT, et mettre en place des actions correctives et préventives pour assurer l'atteinte des objectifs le cas échéants
- Participer au traitement des réclamations et au processus de rappel de lot
- Être le QA référent de la phase de Design transfer des design projects (nouveaux produits et produits commercialisés)
- Piloter les actions de sécurité terrain si nécessaire,
- Contribuer aux audits/inspections des Autorités Compétentes
- Toute autre mission particulière qui pourrait vous être confiée par la Direction.
Votre profil
- Formation de base : Ingénieur, Pharmacien,
- Expérience professionnelle requise : 10 ans d'expérience en industrie pharma et/ou DM
- Connaissance de ISO 13485 / BPF.
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