QC Qualification Specialist
Vor 2 Tagen
TON RÔLE :
En tant que membre de l'équipe QC Projet & Equipement, tu participeras à la mise en place de nouveaux équipements, en suivant les flux de qualification interne (IQ,OQ,PQ). Ces qualifications incluent une partie importante de CSV, pour garantir le respect de la data integrity.
Ton rôle est de conduire notre évolution vers une automatisation accrue et un laboratoire de pointe par la qualification et la validation de nouveaux équipements et systèmes informatisés liés aux méthodes d'analyse, en fonction du calendrier des projets et en respectant la conformité aux BPF.
Tu utiliseras tes compétences en matière de rédaction technique (protocoles et rapports) et de coordination de projets, ainsi que ton expertise en matière de qualification d'équipement et d'intégrité des données.
La réussite du projet dépendra d'une collaboration étroite avec les équipes internes de testing, les services d'ingénierie et de maintenance du site, les services informatiques et les fournisseurs d'équipements externes.
qualifications
TON PROFIL
- Expérience confirmée en matière de qualification/validation d'équipements de laboratoire
- Expérience avec la data integrity
- Expérience confirmée en gestion de projets CSV, incluant la rédaction et exécution de test de validation.
- Connaissance des méthodes d'analyse (physique/bio/chimie) est un plus.
- Expérience dans la coordination de projets, organisé et très autonome.
- Fortes aptitudes à la communication, esprit de collaboration et d'équipe.
- Maîtrise du français/ Bonnes connaissances de l'anglais.
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