Consultant Qualification et Commissioning

il y a 3 semaines

Paris, Île-de-France PQE Group Temps plein

PQE Group : un leader mondial dans les industries de l'industrie pharmaceutique et des dispositifs médicaux


Le groupe PQE est à l'avant-garde de ces industries depuis 1998, avec 40 filiales et plus de 2000 employés en Europe, en Asie et en Amérique. Nous sommes à la recherche d'un Commissioning & Qualification Medior/Senior Consultant basé à Paris, France.


Vous serez chargé(e) de:



  • Mise en service et qualification (supervision des activités FAT, SAT et DQ) pour les installations, Facility, Process, HVAC, Clean Room
  • Rédaction des Risk Assessment /Design Qualification /Validation Plan
  • Validation/Qualification des équipements utilisés dans l'industrie pharmaceutique (par exemple, autoclaves, HVAC, etc.)
  • Rédaction et exécution de protocoles de qualification/validation (QI, QO et QP) et rédaction des rapports correspondants.

Vos qualifications



  • Diplôme d'Ingénieur ou universitaire (Bac + 5),
  • Expérience (3-6 années) en Qualification/Validation dans un contexte GMP Pharma
  • Une expérience directe dans un environnement de fabrication aseptique est fortement souhaitée.
  • Connaissance solide des principes et des guide lignes en matière de C&Q, des BPF de l'UE/FDA et de l'ISPE GAMP 5
  • Capacité à utiliser les instruments de qualification (e-ValPro/DataLogger, etc.) et à collecter les données correspondantes.
  • Excellente connaissance du français (Min C2) et de l'anglais professionnel (Min. B2)
  • La disponibilité à voyager dans tout le pays est constitue un élément fondamental, l'intérêt pour les projets internationaux sera considéré comme un plus.

Prochaines étapes


Si votre candidature correspond à notre demande, le Département de Recruiting vous contactera pour un premier échange RH.


En cas de retour positif, un entretien technique avec le Hiring Manager sera organisé.


Si l'entretien avec le Hiring Manager est positif, le recruteur vous contactera pour établir les étapes suivantes ou pour discuter de notre proposition.


Autrement, si le retour est négatif, nous vous contacterons pour interrompre le processus de recrutement.

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