Senior Specialist Qa Engineering
vor 1 Monat
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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