Chef de Secteur AQP
Le Trait, France Fixed Term Date posted Oct. 11, 2024Intitulé du poste : Chef de Secteur AQP - Remplissage
- Lieu : Le Trait (76 – France)
- Hiring Manager : Mme. Mathilde Outrebon
À propos du poste
Nous fournissons chaque année 4,3 milliards de solutions en soins de santé au monde, grâce à la planification sans faille et au souci du détail de nos équipes Manufacturing & Supply. Grâce à votre talent et à votre ambition, nous pourrons faire encore plus pour protéger les gens contre les maladies infectieuses et apporter de l'espoir aux patients et à leurs familles.
Au sein du département Qualité et sous la responsabilité du Responsable AQP APU de son domaine d’activité et dans le cadre du règlement intérieur et des règles BPF/GMP/HSES en vigueur sur le site : Vous assurez la revue et la libération des lots dans le respect des BPF/GMP ; Suivez et traitez les anomalies internes ; Assurez une veille et un support qualité en production ; Êtes garant du niveau de qualité du secteur dont il est responsable
Principales missions :
- Effectuer la revue des dossiers de lot et préparer la documentation associée dans le respect des BPF/GMP
- Rédiger et approuver la documentation qualité (procédure, formulaire, dossiers de lots, …)
- Gérer les déviations (acceptation, évaluation, approbation de l’investigation) liées à son secteur
- Gestion et suivi des CAPA de son secteur
- Être l’interlocuteur Qualité et le support Qualité pour la Production
- Evaluer et approuver des données techniques dans la GPAO (recette, fiche article, …)
- Assurer l’évaluation AQP des Change Control lors des comités périodiques
- Participer aux groupes de Validation/Qualification/ revue annuelle
- Participer à des projets et s’assurer que le projet suit les procédures qualité site et directives groupe
- Réalisation d’audits et organisation de visites Qualité
- Participation aux audits et inspections du site
- Respecter et faire appliquer les règles HSES
- Respecter et faire appliquer les procédures internes, directives groupe et BPx
- Animer des formations qualité sur le site
- Management direct et/ou indirect si applicable en fonction des besoins de l’organisation
- Réalisation d’astreinte en fonction des besoins de l’organisation
À propos de vous
Expérience :
Expérience en assurance qualité ou Production et connaissance des processus de médicaments stériles et/ou Biotechnologies.
Compétences humaines et relationnelles :
Esprit de synthèse Communication aisée avec des personnes d’autres services ; Rigueur
Compétences métiers et techniques :
- Connaissance en processus de médicaments stérile et des systèmes qualité
- Esprit de synthèse
- Communication aisée avec des personnes d’autres services
- Anglais lu, écrit, parlé
Formation :
Cursus en Pharmacie, Ingénieur ou diplôme de second cycle en sciences biologiques ou chimie.
Langues :
Anglais lu/écrit serait un plus
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We're 20,000 people, working across 28 sites in France with one goal: getting medicines and vaccines to people who need them most. From day one, you'll take on exciting projects to set the course of your career. Whether you're a researcher or a marketer, you'll discover the tools, resources, and support you need to pursue progress. Develop your skills and work in inclusive teams to positively impact millions of people globally.
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