QA Operation Specialist

vor 2 Monaten


CorsiersurVevey, Schweiz Randstad Vollzeit
Description du poste

Pour notre client basé à Corsier-sur-Vevey, au seinde l'équipe QA Operations, nous sommes à la recherche de plusieursQA Operations Specialist pour une durée de 12 à jusqu'à 24 mois.

En tant que membre de l'équipe, vous assurez laconformité et la documentation des activités de lié à lafabrication sur le site. Vous travaillerez en étroite collaborationavec la Production, les fonctions Supports (Data, Engineering,Maintenance, Supply…) ou le partie Processlibération.

Votre rôle :
  • Être le référent QA pour les déviations etdonner les requis pour les les enquêtes/investigationassociées
  • Évaluer et clôturer les déviationsmineures/majeures et identifier lesrécurrences
  • Assister et approuver à ladéfinition des actions correctives et préventives(CAPA)
  • Examiner et approuver les documents GMPslié à votre role.
  • Examiner, approuver etsuivre la documentation cGMP et les propositions de changement(CCP)
  • Participer aux inspections des autoritésde santé et aux audits corporatifs etinternes
  • Respecter les indicateurs qualité afinde libéré les lot à temps pour nos patients et nos clients.



Functie-eisen

Votre profil :

  • Formationscientifique (master de préférences) en biologie, chimie,ingénierie pharmaceutique ou équivalent
  • 3 ansd'expérience dans l'industrie pharmaceutique ou biopharmaceutiquesur un site de fabrication GMP
  • Excellenteconnaissance des Bonnes Pratiques de Fabrication (cGMP) et desenvironnements contrôlés
  • Compétence processusqualité et utilisation avec les outils d'investigation (exemple:Trackwise et SAP)
  • Doté.e d'un bon niveau defrançais et d'anglais, vous êtes reconnu pour votre assertivité,votre capacité à collaborer en équipe et votre proactivité dans lamise en ?uvre d'améliorations.
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