MS&T Engineer Senior
vor 4 Wochen
Vos missions :
A ce poste, vous êtes responsable de l'introduction des formes posologiques solides orales (gélules et comprimés) sur le site pharmaceutique. L'ingénieur senior MS&T rédige, dirige et met à jour le plan de transfert technique et l'analyse des écarts. Vous formez les équipes aux protocoles et aux dossiers de lots principaux du nouveau produit.
Responsabilités
- Vous dirigez les évaluations des risques.
- Vous dirigez les projets et les initiatives selon les directives du client.
- Vous êtes responsable du transfert de technologie et des analyses des écarts ainsi que du suivi du flux d'approbation au sein du système de documentation électronique.
- Vous facilitez la contribution de toutes les parties prenantes pour garantir que les documents sont mis à jour et approuvés en temps opportun en interne et avec le client.
- Vous êtes responsable de l'élaboration du plan de transfert technique et de l'analyse des écarts des nouveaux produits en collaboration avec les services de vrac, d'emballage, et de contrôle qualité.
- Vous êtes le point de contact pour recueillir les commentaires de l'équipe opérationnelle, fournir des commentaires à la direction...
- Soutenir en alignement avec l'assurance qualité et pour l'assurance qualité la définition et la mise en œuvre des attributs de qualité critiques et des paramètres de processus critiques.
- Agir en tant que support du système qualité et de la documentation GMP pour l'équipe des opérations de fabrication
- Soutenir les activités de fabrication et d'emballage liées à l'introduction de nouveaux produits sur le terrain avec l'équipe de production si nécessaire.
- Collaborer avec l'assurance qualité et les opérations d'emballage ou de vrac pour garantir que les évaluations et les enquêtes sont exhaustives.
- Participer activement à l'amélioration continue.
- Suivi et mise en œuvre les CAPA assignés.
Votre profil :
- Vous êtes diplômés d'une licence ou un master en ingénierie ou expérience équivalente
- Vous avez au moins 5 ans d'expérience dans l'industrie pharmaceutique avec une expérience importante dans l'introduction de nouveaux produits avec les formes OSD.
- Bonnes connaissances des réglementations internationales en vigueur, des exigences cGxP et des pratiques, notamment 21 CFR partie 11, 210 et 211, annexe 11, directives EU-GMP et GAMP
- Connaissance des installations pharmaceutiques, de la fabrication et des systèmes et processus de laboratoire.
- Solides compétences analytiques et de résolution de problèmes.
- Excellentes compétences en organisation et en gestion de projet,
- Français et anglais fluent.
Branche:
Funktion:
Anstellungsart: Festanstellung
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