Quality Associate
Il y a 2 mois
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today
En tant que contact qualité pour l’organisation Elanco Affiliate (site exploiant), le Quality Associate manage les activités qualité en lien avec la distribution des produits Elanco en France. Le Quality Associate s’assure que toutes les opérations de la filiale sont conformes à la règlementation locale et aux standards qualité d’Elanco.
Le Quality Associate assiste le Quality Manager pour assurer une surveillance indépendante de la qualité des fournisseurs de services GMP et doit s'assurer que les produits importés répondent à la qualité attendue par les clients.
Rôle et responsabilités:
Travailler avec le Quality Manager afin de garantir que toutes les activités de la filiale respectent les GxP applicables ainsi que les autres normes de qualité applicables au sein de l'entreprise et la règlementation localePoursuivre une amélioration continue et minimiser le risque par une auto-évaluation de routine, des actions correctives et préventives (CAPA) et l'utilisation d'un plan de qualitéRemonter toutes les problématiques liées à la qualité du produit à l’équipe qualité régionale ainsi que l’équipe de management de la filiale et prendre en charge les actions définies le cas échéant (rappel, contrefaçon, etc.)Responsable de l’exécution des tâches qualité opérationnelles, y compris, mais sans s'y limiter, la gestion des déviations, la gestion des changements, la revue et l’approbation des procédures et le maintien et le suivi du plan qualitéVeiller à ce que la distribution, la libération du produit et l'entreposage soient conformes aux normes Elanco et aux exigences réglementaires externes (exemple. Produits retournés / réintégrés, rappel des produits).Ouvrir les « notification to management » si nécessaireSuivre, identifier et interpréter les indicateurs qualité (Quality metrics)Respecter toutes les politiques locales et globales de l'entreprise, y compris les cadres de la qualité, le code de conduite, la RSE, la lutte contre la discrimination, le harcèlement et les politiques de santé, de sécurité et d'environnementResponsable de la mise en place et du maintien des actions qualité en lien avec la certification GMP+. Ces activités incluent par exemple : maintien du manuel qualité, matrice RASCI, auto-inspection annuelle, simulation de rappel de lot. Le Manager Qualité filiale est membre de l’équipe HACCPPossibilité d’inscription en tant que Responsable Pharmaceutique Intérimaire.Coordonne le management local des réclamations qualitéEffectue toute autre tâche ou toute autre fonction qui peut être déterminée par la direction de la Société.Profil:
Formation : Bac+4 en pharmacie , en sciences, en ingénierie ou dans un domaine connexe
Expérience :
Expérience précédente dans un environnement GxPCapacité à travailler en équipeCapacité de communication (écrite et orale), compétences en présentationExpérience dans la participation à des inspections réglementairesCapacité d'investigation et d'analyseCapacité de planification et d'organisationSupplémentaire Préférences :
Anglais courant (parlé et écrit)Connaissance en gestion des stocks-
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