Quality Assurance Coordinator

Il y a 3 mois


Lyon, France BI AH France SCS Temps plein

**Proposer des traitements innovants en Santé Humaine et Animale - c’est l’engagement de Boehringer Ingelheim depuis plus de 130 ans. Boehringer Ingelheim est une entreprise familiale, engagée dans la recherche et développement, et qui figure parmi les 20 premières entreprises du médicament au monde. **Nos collaborateurs créent tous les jours de la valeur par l’innovation dans les domaines de la Santé Humaine, de la Santé Animale et la fabrication de produits biopharmaceutiques en sous-traitance.**

**Boehringer Ingelheim Animal Health France s’engage pour améliorer la santé animale. Avec plus de 10 000 collaborateurs dans le monde, la division Santé Animale de Boehringer Ingelheim propose des produits sur plus de 150 marchés et est présent dans 99 pays.
**Le Service Assurance Qualité Commerciale et Conformité recrute **un(e) Coordinateur Assurance Qualité et Conformité, F/H en CDI, sur le site de Lyon (Gerland).
**Rôle et responsabilités**:

- Rattaché(e) au Responsable du Service Assurance Qualité Commerciale et Conformité, vous assurerez la mise en œuvre opérationnelle des processus qualité et conformité majeurs, en étroite collaboration avec les Responsables Assurance Qualité et/ou Conformité du service.
- En Assurance Qualité Commerciale, vos activités seront principalement dédiées à la libération commerciale des lots pour les marchés français et export, la prise en charge des réclamations qualité produits, l’administration de la formation des collaborateurs impliqués dans les activités pharmaceutiques.
- En Conformité Vétérinaire, vous assurerez la gestion des conventions et des obligations de transparence conformément à la Loi d’Avenir pour l’Agriculture, l’Alimentation et la Forêt (LAAAF).
- En coordination avec les autres Coordinateurs du Département Réglementaire et Qualité, vous assurerez l’accueil téléphonique pour les demandes d’information médicale vétérinaire (IMV).

**Principales missions**:
**Libération commerciale**:

- En collaboration et coordination avec l’équipe Assurance Qualité, assurer quotidiennement la constitution et le suivi des dossiers de libération commerciale, en assurant le premier niveau de contrôle des données de réception transmises par le(s) dépositaire(s).
- Organiser et prioriser les dossiers de libération commerciale dans les délais requis et en fonction des priorités Business et Supply, en particulier en cas de rupture ou risque de rupture marché.
- Assister les Responsables Qualité et Qualified Person dans la gestion des non-conformités à réception, en lien avec les équipes Supply, le(s) dépositaire(s) et les sites fabricants.

**Réclamations Qualité Produits**:

- Assurer la réception, l’enregistrement et l’assignation des réclamations qualité aux sites investigateurs dans l’outil GoTrack (Trackwise), dans les délais requis.**:

- Respecter les délais d’enregistrement des réclamations en fonction de la criticité du défaut et assurer, sans délai, l’information du management et du Responsable Pharmaceutique en cas de défaut critique ou majeur avec potentiel rappel de lot.**:

- Organiser la reprise des unités défectueuses et s’assurer de la conformité des demandes de remplacement du produit.**:
**Administration de la formation du personnel**:

- En collaboration avec les Responsables Qualité, assurer le rôle d’administrateur du système de gestion de la formation (LOS), pour la mise en œuvre et le suivi des plans de formation qualité et pharmaceutique du personnel.
- Assurer l’assignation et l’enregistrement des formations initiales et continues dans le système LOS, l’organisation des sessions de formations et le premier niveau d’assistance auprès des utilisateurs.

**Supports opérationnel et administratif du Responsable de Service et des Responsables Assurance Qualité et/ou Conformité**:

- Assister l’équipe dans ses activités opérationnelles et documentaires (gestion des déviations, rédaction de procédures, constitution de dossiers type dossier d’Etablissement, dossiers de rappel de lot).
- Participer à l’archivage des documents et aux tâches administratives du Service AQ (organisation de réunions, comptes-rendus, mises en signatures de contrats et cahiers des charges, courriers,).

**Service clients (Information Médicale Vétérinaire)**:

- Assurer le premier niveau d’assistance aux clients pour les demandes d’information médicale, les déclarations de PV ainsi que les réclamations qualité, en assurant la traçabilité des informations et l’intégrité des données dans les outils dédiés.**:

- Être en mesure d’identifier le type de demande et l’adresser aux bons interlocuteurs internes dans les plus brefs délais, en particulier aux Services Techniques, Pharmacovigilance ou Qualité et assurer le suivi des réponses apportées.**:
**Conformité Vétérinaire**:

- Assurer la gestion et la pu



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