FR - EMEA, CSL Vifor
January 8, 2025
CSL VIFOR est un leader mondial dans les domaines de la carence en fer et des traitements de l'anémie ferriprive, et notre histoire a débuté en 1872, lorsqu'un pharmacien du nom de Caspar Friedrich Hausmann a ouvert une pharmacie à Saint-Gall, en Suisse.
Nous plaçons les patients au centre de toutes nos activités. En collaborant étroitement avec les médecins, les patients et les associations de patients, nous répondons aux besoins médicaux non couverts pour lesquels il n'existe actuellement pas ou peu d'options thérapeutiques grâce à la conclusion de partenariats visant à obtenir de nouvelles licences et à des développements internes.
Dans le cadre d'un remplacement de congés maternité, nous recherchons un Pharmacien inscriptible à l'Ordre (section B) disponible à partir de mars 2025.
Le site de Vifor France basé à la Défense dispose du statut de fabricant importateur et le département Assurance Qualité Opérations Europe a pour mission d'effectuer la certification des lots en vue de leur commercialisation en Europe (EU-release).
Vos activités et responsabilités :
• Assurer la certification des lots de produits finis (formes orales) en vue de leur commercialisation en Europe et dans les pays reconnaissants la certification EU
• Assurer la revue des dossiers de lots et garantir leur conformité. Gérer les déviations et les réclamations qualité et mettre en place les actions correctives et préventives nécessaires.
• Contrôler les documents qualité nécessaire à la certification et assurer la gestion de l'échantillothèque
• Gérer le contact avec les distributeurs, notamment pour autoriser la certification des lots pour la vente EU
• Assurer la traçabilité des libérations effectuées (Registre de certification des lots pour le marché Européen)
• Collaborer avec le département export de VIFOR global pour la gestion des stocks EU ainsi qu'avec tous les départements assurance qualité de Vifor global
• Participation à la gestion du système qualité (Déviation, CAPA, Change control, Système documentaire, réclamation)
• Réaliser toutes les missions qualité demandées par le supérieur hiérarchique ou le Pharmacien Responsable de Vifor France.
Dans ce rôle, vous vous engagerez à mener tous les aspects de vos activités de manière éthique et transparente et vous vous assurerez du respect et de la mise en conformité aux lois, réglementations, directives, politiques et procédures de l'entreprise locales et internationales applicables dans toutes les activités de l'entreprise, que ce soit directement ou par l'intermédiaire de tiers.
Formation initiale et expérience
Niveau de formation :
Doctorat en Pharmacie (thèse soutenue) / Master en Assurance Qualité
Expérience Professionnelle
Une première expérience réussie dans des fonctions similaires ou en Assurance Qualité
Une expérience sur site de fabrication est un avantage
Connaissances spécifiques :
Bonnes connaissances des Bonnes Pratiques de Fabrication et de l'annexe 16.
Connaissances en production et/ou distribution
Connaissances en langue étrangère :
Anglais lu, écrit et parlé
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
For more information, please visit viforpharma.com
We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Vifor!
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