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QA Operation Specialist
vor 3 Monaten
Pour notre client basé à Corsier-sur-Vevey, au sein de l'équipe QA Operations, nous sommes à la recherche de plusieurs QA Operations Specialist pour une durée de 4 mois pouvant être prolongé jusqu'à 24 mois.
En tant que membre de l'équipe, vous assurez la conformité et la documentation des activités de lié à la fabrication sur le site. Vous travaillerez en étroite collaboration avec la Production, les fonctions Supports (Data, Engineering, Maintenance, Supplyâ¦) ou le partie Process libération.Votre rôle :
- Ãtre le référent QA pour les déviations et donner les requis pour les les enquêtes/investigation associées
- Ãvaluer et clôturer les déviations mineures/majeures et identifier les récurrences
- Assister et approuver à la définition des actions correctives et préventives (CAPA)
- Examiner et approuver les documents GMPs lié à votre role.
- Examiner, approuver et suivre la documentation cGMP et les propositions de changement (CCP)
- Participer aux inspections des autorités de santé et aux audits corporatifs et internes
- Respecter les indicateurs qualité afin de libéré les lot à temps pour nos patients et nos clients.
qualifications
Votre profil :
- Formation scientifique (master de préférences) en biologie, chimie, ingénierie pharmaceutique ou équivalent
- 3 ans d'expérience dans l'industrie pharmaceutique ou biopharmaceutique sur un site de fabrication GMP
- Excellente connaissance des Bonnes Pratiques de Fabrication (cGMP) et des environnements contrôlés
- Compétence processus qualité et utilisation avec les outils d'investigation (exemple: Trackwise et SAP)
- Doté.e d'un bon niveau de français et d'anglais, vous êtes reconnu pour votre assertivité, votre capacité à collaborer en équipe et votre proactivité dans la mise en ?uvre d'améliorations.
- Orienté résultats
