QA Operational

vor 10 Stunden

Lausanne, Waadt, Schweiz Gi Group Vollzeit

Pour notre partenaire, situé dans le canton de Vaud, GI Life Sciences recherche un.e :

QA Operational

Poste temporaire

Prise de poste : ASAP

Durée : 9 mois

Votre mission :

Ce poste a pour mission de garantir la qualité et la conformité des produits fabriqués sur le site, en veillant au respect des Bonnes Pratiques de Fabrication (BPF) et des standards de l'entreprise. Il implique la responsabilité de la libération technique des lots. Le titulaire du poste contribue à maintenir des processus robustes et conformes aux exigences réglementaires, tout en soutenant l'amélioration continue et la fiabilité des opérations.

Vos responsabilités :

  • Assurer la libération technique des produits finis, vrac et API en garantissant leur conformité aux BPF.
  • Vérifier et maintenir à jour la documentation qualité (MBR, SOP, IDR) pour garantir la conformité.
  • Identifier, analyser et traiter les écarts par rapport aux exigences qualité et mettre en œuvre les actions correctives et préventives.
  • Proposer et piloter des initiatives visant à améliorer la qualité, la sécurité, l'efficacité et la maîtrise des coûts.
  • Bloquer/débloquer les lots en cas de problème qualité et assurer la traçabilité des décisions.
  • Agir comme interlocuteur unique avec les équipes Supply Chain et les marchés pour résoudre les non-conformités, urgences ou ruptures.
  • Garantir la disponibilité des certificats de lots et la conformité aux autorisations de mise sur le marché.
  • Contribuer aux procédures PIRC/Recall (extraction, compilation et suivi des données).
  • Approuver les rapports de monitoring environnemental et veiller au respect des standards qualité.

Votre profil :

  • Master en sciences pharmaceutiques idéalement ingénieur ou pharmacien.
  • Minimum 5 ans dans l'industrie pharmaceutique, avec expertise en assurance qualité, libération de lots, BPF.
  • Maîtrise du français et de l'anglais.
  • Maîtrise des procédés de fabrication et conditionnement.
  • Leadership, prise de décision claire, orientation qualité et résultats.

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