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CDD - Support Assurance Qualit-- EM API H/F

Company: SANOFI
Location: New Orleans
Posted on: November 11, 2019

Job Description:

Bas? sur le site de CSVB, Le Support Assurance Qualit? EM API doit assister le responsable qualit? EM API dans la gestion du syst?me d?Assurance Qualit? de l?activit? d'achat/revente de principes actifs et d'excipients, activit? d?clar?e aupr?s des autorit?s de sant? (ANSM) et de l?activit? de mise ? disposition de mati?res premi?res ? usage pharmaceutique (MPUP).Ce poste s?inscrit dans un contexte de surcroit temporaire d?activit? pour prise en compte de la gestion de nouveaux flux et des nouvelles r?glementations li?es aux impuret?s g?notoxiques.PRINCIPALES RESPONSABILIT?SAssister le responsable qualit? EM API :-? Pour la reprise de la gestion de flux de principes actifs pour les CMO d'External Manufacturing CHC et Europe (Gentilly)

  • Mettre en place des agr?ments qualit? et des accords sur sp?cifications avec les fournisseurs
  • Collecter la documentation qualit? obligatoire (QSMP, ICHQ3D, nitrosamines, PDE, MSDS, etc...)
  • Int?grer la gestion de ces fournisseurs dans le planning d'audits??????????????-? Pour la gestion du syst?me d?Assurance Qualit? de l?activit? d'achat/revente de principes actifs et d'excipients, activit? d?clar?e aupr?s des autorit?s de sant? (ANSM) et de l?activit? de mise ? disposition de mati?res premi?res ? usage pharmaceutique (MPUP)
    • Aider ? la pr?paration de l'audit du service (suivi des change control, des d?viations, des r?clamations, aide ? la r?daction ou ? la mise ? jour de documentation qualit?).
    • ?Aider ? la prise en compte des nouvelles r?glementations li?es principalement aux impuret?s g?notoxiques (ICH M7)REQUIS POUR LE POSTE?
      • Niveau BAC + 5 minimum (Ing?nieur d?butant, Chimiste, Pharmacien) ou exp?rience d?au moins 3 ans en Assurance Qualit?
      • Connaissance des BPF (ICH Q7) ? GDP API
      • Utilisation des outils PHENIX modules CC, QTP et E&CAPA, GEODE +
      • Anglais obligatoire, ?crit, lu? et parl?
      • Autonomie, rigueur, m?thodologie, communication, travail en ?quipeCDD de 9 mois renouvelable#LI-FRAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

Keywords: SANOFI, New Orleans , CDD - Support Assurance Qualit-- EM API H/F, Other , New Orleans, Louisiana

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