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QA Documentation

vor 1 Monat


Le Vaud, Schweiz Axepta SA Vollzeit

Notre client, entreprise internationale pharmaceutique en pleine croissance, recherche un **spécialiste QA **pour son site de production biomanufacturing basé dans le** Nord Vaudois**.

Responsabilité:

- Gérer l'assurance qualité du DMS et QMS, ainsi que la documentation et les formations. Gestion du classement et de l'archivage.
- Former et assurer l'intégration dans le système de qualité, les soutenir dans leurs taches en système qualité. Diffusion de la documentation du département.
- Être le point de contact pour les dépannages et soutenir le département dans la définition de la stratégie de formation.
- Participer à l'amélioration continue du système de documentation et de formation.
- Gérer les tableaux de bords, suivre le SMQ et préparer les KPI. Maintenir le journal des entrées et sorties.
- Mise à jour des formations et procédures.
- Participer aux audits internes et préparer le site aux inspections réglementaires
- Valider les changements, les déviations, les CAPA.

Profil:

- Bon niveau d'anglais.
- Expérience en assurance qualité dans le domaine pharmaceutique ou des dispositifs médicaux.
- Maitrise des BPF.
- Certification de formateur un atout.