Production Compliance Specialist
vor 4 Wochen
Nous recherchons pour notre client Merck un.e Compliance Production Specialist, pour une mission d'une durée de 12 mois.
Vos Missions:- Assurer la gestion des déviations, CAPA, Change Control liés à l'activité aseptique.
- Prendre en charge la rédaction de l'ensemble de la documentation liée aux activités aseptiques.
- Prendre en charge les observations en chambre liées au comportement aseptique des opérateurs de production.
- Supporter la production de l'ensemble du département aseptique.
- Coordonner la revue des dossiers de production FDF d'un point de vue cohérence du contenu et respect des règles GMP.
- Participer à l'élaboration et à la rédaction de la documentation opérationnelle nécessaire à la bonne réalisation des activités de production aseptique.
- Participer aux différents projets techniques, équipements et procédés en lien avec son périmètre d'activités.
- Gérer toutes les non-conformités et actions qualité en relation avec son périmètre d'activités selon les procédures locales en vigueur.
- Collaborer activement avec les autres départements de MS-A : QA pour les déviations, QC pour le prélèvement des échantillons, Service Technique pour la maintenance des équipements, Magasin pour la réception des commandes, Contrôle Visuel pour le suivi de la qualité des lots semi-finis.
Votre Profil:
- Connaissance en BPF.
- Connaissance en gestion de production aseptique.
- Utilisation des outils informatiques (Excel, Word).
- Bonne expérience en milieu pharmaceutique.
- Français et anglais écrit et parlé.
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