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Qc Project Manager
vor 3 Wochen
**QC Project Manager** - Neuchâtel
Missions:
- Gestion de toutes les activités de transfert et de validation des méthodes analytiques.
- Gestion de la coordination des protocoles et des rapports de transfert, validation des méthodes selon les besoins.
- Coordonner la mise en place des données de base du contrôle qualité, y compris au sein du LIMS, d'Empower et de l'équipement, et s'assurer que les systèmes d'interface ERP, MES, etc. sont correctement configurés.
- Coordonner la création et/ou la mise à jour des méthodes, spécifications, formulaires, etc. pour le transfert de nouveaux produits.
- Coordonner les tests d'entrée (API, matières premières, emballage), de validation et de libération des lots techniques, d'ingénierie et PPQ.
- Coordonner la mise en place du programme de stabilité.
- Être référent pour les défis analytiques, le dépannage et les besoins de traitement liés à l'activité de transfert en cours.
- Interpréter les données analytiques dans le contexte approprié des produits fabriqués et des tests effectués pour garantir la qualité des produits fabriqués. Cela inclut l'examen des ensembles de données chimiques et physiques.
- Fournir un soutien à l'investigation et à l'examen de tous les écarts analytiques/incidents hors spécifications liés aux efforts de qualification/validation ainsi qu'à la production de lots commerciaux en cours.
Profil:
- Expérience en matière de transfert et de validation de méthodes de dosage de substances solides par voie orale (OSD).
- Bonne compréhension de l'équipement analytique OSD et des processus d'essai et chromatographie (HPLC, LPC et GC), la dissolution, les titreurs, les spectrophotomètres, les analyses microbiologiques, les essais d'emballage ou d'autres analyseurs élémentaires.
- Connaissance pratique des attentes en matière de contrôles analytiques qui découlent de la norme 21CFR210/211 FDA
- Expérience de la rédaction technique dans un contexte scientifique (SOP, protocoles, certificats, etc.).
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