Quality and Continuous Improvement Expert in
Il y a 5 mois
**Mission de la fonction**
Le QO spécialiste supporte les stratégies visant à renforcer la maturité de la culture qualité et l’excellence opérationnelle de son département
**Contexte du poste et de la fonction**
**Contenu de la fonction**
Coaching:
- Coach et supporte la rédaction et la complétion de l’ensemble de la documentation relative à la production tel que dossiers de campagne, analyses de risque, Batch Record, SOP, work instruction.
- Supporte et facilite la rédaction et la clôture dans les temps des déviations/CAPA/Change Control/OOS.
- Coach le développement des équipes pour les investigations root cause, les impact assessments et définition de CAPA relevant de déviations complexes/inter-départements
Amélioration continue:
- Agit en tant que facilitateur qualité et mène les initiatives de simplification, harmonisation et d’amélioration continue dans le scope des activités de production ainsi que des systèmes qualité.
- Supporte l’implémentation, l’harmonisation et la simplification des matrices de formation du département
- Recherche les causes de dysfonctionnements et y apporter des actions correctives
- Applique et soutient la politique 5S
- Expertise:
- S’assure que les documents associés aux zones opérationnelles sont compliants par rapport aux requis GMP en vigueur et aux policies Thermofisher
- Participe activement aux audits (interne, corporate et externe des clients) et inspections des autorités.
Performance:
- Utilise les outils de communication pour assurer le suivi des actions qualité (déviations, CC, CAPAs via les Tier meeting, Deviation Review Board, Comité CAPA, Comité CC, Project readiness board)
- Suit les indicateurs de performance et escalade toute dérive en proposant un plan d’action
**Complexité de la fonction**
La fonction de QO Specialist requiert une rigueur organisationnelle et documentaire afin de respecter les requis liés aux Bonnes Pratiques de Fabrication (GMP).
Le QO Specialist doit également faire preuve d’agilité et d’assertivité pour la facilitation des investigations et la résolution des issues rencontrées en production.
**Connaissances et niveau d'éducation**
- Master, PhD, pharmacien ou ingénieur dans les domaines de la Biologie, Biotechnologie ou Bioingénierie, ou niveau équivalent acquis par l’expérience
- Expérience professionnelle d'au moins 2 ans dans un environnement industriel pharmaceutique
- Expérience confirmée en GMP
- Pratique aisée de l’anglais (écrit et parlé)
- Aptitudes rédactionnelles
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