QA R&D Specialist
vor 4 Wochen
Nous recherchons un QA R&D Specialist pour l'un de nos clients, entreprise pharmaceutique leader dans son domaine d'activité et basée sur le canton de Genève.
Rejoignez une entreprise internationale produisant des produits pharmaceutiques à haute valeur ajoutée dans le cadre d'un renfort temporaire d'1 an pour travailler sur l'ensemble du Système Qualité des laboratoires et centre de recherche du site de production.
Responsabilités :
- Améliorer, mettre en ?uvre et maintenir les systèmes qualité sous les référentiels GLP et GMP.
- Examiner/approuver la publication des documents relatifs à la qualité pour les laboratoires.
- Vérifier la conformité qualité des plans et rapports d'études pour assurer leur conformité aux GLP.
- Superviser les activités de qualification/validation des laboratoires et les interventions des fournisseurs/sous-traitants.
- Traiter les déviations, les investigations, les CAPA et le change control.
- Participer aux audits internes pour la conformité aux GxP.
- Soutenir les audits externes et les inspections des autorités réglementaires sur le site.
Votre profil :
- Diplôme en chimie, pharmaceutique ou biochimie, justifiant d'à minima 3 ans d'expérience en assurance qualité pour l'industrie pharmaceutique ou biotech.
- Expérience significative pour l'assurance qualité au sein des laboratoires et parfaite maitrise des GLP.
- Bonnes connaissances des réglementations et normes GMP.
- Français et Anglais courant exigé.
Pour plus d'informations, merci de contacter Morgane CAYUELA à morgane.cayuela@axepta.com
Branche: Pharma-Industrie
Funktion: Forschung und Entwicklung
Anstellungsart: Temporäre Arbeit
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