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Compliance Specialist Biotech

vor 3 Monaten


Aubonne VD, Waadt, Schweiz Randstad Vollzeit
Nous sommes à la recherche d'un.e Compliance Specialist Biotech pour notre client, Merck, pour une mission d'une durée de 12 mois.

Votre rôle :

Le/la Compliance Specialist Biotech aide à assurer la compliance au sein de l'équipe Compliance au Manufacturing Operational Support, en respectant les cGMPs, et en assurant l'exactitude de la documentation. Il contribue à maintenir les exigences qualité en participant aux Déviations, CAPAs, Change control et la revue documentaire.

Activités :

• Contrôler et consolider les dossiers de production dans son domaine d'activité (revue finale et transfert au QA)

• Participer à l'effort de résolution des déviations, CCPs et CAPAs dans les temps

• Effectuer le maintien, la revue et la gestion des procédures et/ou d'autres documents nécessaires pour maintenir le statut GMP des activités exécutées dans son domaine d'activité

• Effectuer des Gemba hebdomadaires dans les zones de production

Votre profil idéal :

• Formation d'Ingénieur de biotechnologie / sciences de la vie / santé ou diplôme équivalent

• Notions des normes GMP et réglementation en vigueur pour la production des principes actifs

• Notions des comportements en environnement pharmaceutique

• Connaissances des principes de fabrication de protéines dans un contexte de production pharmaceutique

• Maîtrise des logiciels de bureautique
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