Production Compliance Specialist

Vor 2 Tagen

Aubonne, Schweiz Randstad Staffing Vollzeit

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.
- Prend en charge la rédaction de l'ensemble de la documentation liée aux activités aseptiques.
- Prend en charge les observations en chambre liées au comportement aseptique des opérateurs de production.
- Support production de l'ensemble du département aseptique.
- Coordonne la revue des dossiers de production FDF d'un point de vue cohérence du contenu et respect des règles GMP.
- Participe à l'élaboration et à la rédaction de la documentation opérationnelle nécessaire à la bonne réalisation des activités de production aseptique.
- Participe aux différents projets technique, équipements et procédés en lien avec son périmètre d'activités.
- Gestion de toutes les non-conformités et actions qualité en relation avec son périmètre d'activités selon les procédures locales en vigueur.
- Collabore 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.

Qualifikationen

Votre Profil:

- Ingénieur (Bachelor/Master ou équivalent)

- Formation dans le domaine de la chime, biologie ou biotechnologie

- 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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