DSP Compliance Expert
Vor 3 Tagen
Nous sommes à la recherche d'un DSP Compliance Expert (m/f/d) pour une durée de 12 mois.
Votre rôle
Au sein du département Manufacturing, vous intégrez l'équipe DSP (Down Stream Processing), une équipe performante et dynamique constituée de techniciens et d'ingénieurs, spécialisés dans la purification de protéines recombinantes produites à partir de cellules animales.
Vous reporterez directement au Responsable d'Unité DSP et allez être acteur de la production commerciale du pipeline de la compagnie.
Vous êtes en charge des activités compliances encadrant le suivi du procédé : gestion des déviations de leur ouverture à la mise en place de CAPA. Revue et suivi de batch process (BRP) afin de permettre la libération des lots produits. Sensibilisation de l'équipe de production DSP aux BPF, règles GMP. Suivi et gestion de la formation des collaborateurs de production.
Qualifications- Capacité d'intégration à une équipe avec un sens aigu de la qualité (GMP) et de la performance
- Est pro-actif dans l'accomplissement des tâches relatives au poste et sait gérer les priorités
- Forte conscience et application des règles GMP
- 2-5 ans d'expérience dans le domaine de la production chimique/pharmaceutique/biotechnologique
- Expérience DSP est souhaitée
- Français courant, anglais (compréhension écrit et lu, un plus)
- Agilité d'intégration des outils informatiques (Discoverant, MES, Trackwise)
Estelle Kotelon
Randstad Merck Aubonne
#J-18808-Ljbffr-
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