Chargé Assurance Qualité Produit & Libération des Lots
Zeralda, Algeria Fixed Term Date posted 26/06/2024Missions:
- Assurer la mise en place et le suivi des actions définies dans son secteur d’action en vue d’assurer le bon fonctionnement de l’APU
- Participer aux opérations de validation au site de Sidi Abdellah.
- Participer au programme d’auto-inspection du site en assurant la conduite, le reporting et le suivi de la mise en place des actions.
- Veiller au suivi des opérations de validation conformément au protocole de validation et dossiers de lots.
- Préparation des dossiers de lots de fabrication, de conditionnement et d’impression vignettes.
- Participer à la revue des dossiers de lots fabriqués (ou conditionnés) sur le site de Sidi Abdellah en vue de leur libération :
Dossier de lot de fabrication,
Dossier de lot de conditionnement,
Dossier de lot analytique.
Libérer (ou refuser s’il y a lieu) les lots fabriqués (ou conditionnés) sur le site de Sidi Abdellah.
- Gérer le système de libération des lots de produits finis fabriqués (ou conditionnés) sur le site.
- Assurer la gestion des déviations en cours en assurant notamment :
- L’indentification de la déviation,
- L’ouverture de l’enquête,
- Le suivi de l’enquête en collaboration avec les différents départements concernés,
- La proposition d’actions correctives et préventives et des revues d’efficacité
- La rédaction du rapport de l’enquête s’il y a lieu,
- Décision du statut final en collaboration avec le Responsable Qualité site pour les déviations majeures et critiques.
- Réalisation des revues d’efficacité des CAPA's
- Traitement de réclamations
- Réalisation des analyses de tendances périodiques : trending deviations, CAPA's, ER, réclamations.
- Participer à la formation périodique du personnel du site de Sidi Abdellah et aux enregistrements qui en découlent.
- Elaborer, dans les délais impartis, la Revue Annuelle des Produits fabriqués ou conditionnés sur le site. En faire l’analyse et proposer les plans d’améliorations.
- Participer activement aux investigations dans le cadre de la gestion des réclamations, en transmettant dans les temps impartis les résultats de l’investigation au Responsable Assurance Qualité Produit.
- Participer à la rédaction des procédures qualité du site conformément aux directives, standards et guides du groupe.
- S’inscrire dans la démarche d’amélioration continue en réalisant des tournées terrain , process confirmation et en participant aux différents projets.
- Contribuer à la mise en place de la culture qualité sur le site de Sidi Abdallah en conduisant ou en accompagnant les différentes initiatives.
- Respecter et faire respecter les politiques Qualité et HSE de Sanofi au sein du site.
Compétences:
- Connaissance avancées des systèmes Qualité et des bonnes pratiques de fabrication.
- Connaissance avancées des process de production pharmaceutique.
- Maitrise des méthodes d’investigation
- Connaissancedes méthodologies d’évaluation des risques qualité.
- Connaissance des systèmes d’amélioration continue.
- Bonne connaissance en analyse de données et statistiques.
- Sens de l’organisation et de priorisation.
- Esprit d’analyse et de synthèse.
- Compétences interpersonnelles développées et bonne communication
- Niveau d’anglais : Intermédiaire.
Formation / Expérience professionnelle:
- Au minimum diplômé Bac+4/Bac+5 en pharmacie, génie des procédés ou équivalent.
- Un minimum de 2 ans d’expérience avérée dans un poste similaire en industrie pharmaceutique.
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