MS&T Engineer Senior

vor 4 Wochen


Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit
Pour notre partenaire situé dans le canton de Neuchâtel, GI Life Sciences, recherche un(e) : MS&T Engineer senior.

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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