Senior specialist QA engineering

vor 1 Woche


Lausanne, Waadt, Schweiz Axepta SA Vollzeit

Responsabilités :

  • Supervision du commissioning, calibration, maintenance, qualification.
  • Supervision de la qualité du monitoring des utilités et locaux.
  • Collaboration et suivi avec les services d'ingénierie et de QC.
  • Approbation des SOP afin de garantir la conformité.
  • Veille de la conformité des activités d'ingénierie en lien avec les BPF.
  • Gestion des déviations et investigation.
  • Proposition et validation des plans de CAPA et gestion et mise en œuvre des changes.
  • Participation aux évaluations des risques et aux améliorations continue.
  • Référent QA pour le département ingénierie lors des inspections.
  • Soutien aux programmes d'audit.
  • Assure la suppléance du CSV.

Profil :

  • Licence en ingénierie chimique, bio-ingénierie, bioprocédés ou équivalent.
  • Maitrise de l'anglais et du français.
  • 5 ans d'expérience en Assurance Qualité dans un environnement biopharmaceutique.
  • Expérience dans la qualification d'équipements et la validation de systèmes informatisés.
  • Expérience CSV un atout.
  • Maîtrise des bonnes pratiques cGMP.
  • Flexibilité et capacité à voyager.
  • Disponible dès Juin.


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