Quality Assurance Specialist
4 weeks ago
Nous recherchons un Quality Associate pour rejoindre notre équipe qualité à Dechra. Ce poste est responsable de l'assurance de la qualité des produits pharmaceutiques importés sur le marché canadien.
Responsabilités- Maintenir le système de gestion de la qualité associé à la fourniture de produits au marché CA
- Gérer les activités autorisées garantissant l'exactitude et la qualité des enregistrements
- S'assurer que les programmes de formation initiale et continue sont mis en œuvre et maintenus
- Coordination des activités de rappel
- Fournir un examen CA et travailler avec des équipes interfonctionnelles impliquées dans la gestion des plaintes clients pertinentes
- S'assurer que les fournisseurs sont approuvés
- Soutenir l'approbation de toute activité sous-traitée susceptible d'avoir un impact sur le PIB
- Soutenir le programme d'auto-inspections
- Tenir des registres appropriés de toutes les tâches déléguées
- Collecte et examen de la documentation requise pour permettre l'élimination des produits retournés, rejetés, rappelés ou falsifiés
- Collecte et examen de la documentation requise pour permettre l'approbation de tout produit retourné
- S'assurer que toutes les exigences supplémentaires imposées à certains produits par la législation nationale sont respectées
- Compiler et examiner les indicateurs de performance clés (KPI) appropriés
- Évaluation de l'efficacité du SMQ du site
- Examiner le SMQ actuellement en vigueur sur le site
- Travailler avec les principales parties prenantes
- S'assurer que les exigences des BPD sont intégrées dans les activités de logistique et de chaîne d'approvisionnement
- Assurer une communication interfonctionnelle efficace
- Soutenir les audits des fabricants sous contrat, des fournisseurs, des organismes de réglementation et des clients
- S'assurer que les situations susceptibles de compromettre la qualité sont mises en évidence
- Diplôme universitaire en science liée au travail effectué
- Minimum 2 ans d'expérience pratique pertinente dans un rôle de qualité
- Bilinguisme français-anglais complet
- Expérience avérée en qualité pharmaceutique
- Connaissance des processus de fabrication, d'emballage, de test et de distribution pharmaceutiques
- Connaissance des exigences réglementaires GMP/GDP
- Expérience dans le soutien aux inspections réglementaires, aux audits des fournisseurs et aux auto-inspections
Dechra offre un environnement de travail inclusif et dynamique. Nous sommes fiers de notre culture et de notre famille de près de 2 000 collègues dans le monde. Nous sommes particulièrement ravis d'entendre parler de ceux qui ont/sont :
- Diplôme universitaire en science liée au travail effectué
- Minimum 2 ans d'expérience pratique pertinente dans un rôle de qualité
- Bilinguisme français-anglais complet
- Expérience avérée en qualité pharmaceutique
- Connaissance des processus de fabrication, d'emballage, de test et de distribution pharmaceutiques
- Connaissance des exigences réglementaires GMP/GDP
- Expérience dans le soutien aux inspections réglementaires, aux audits des fournisseurs et aux auto-inspections
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