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Consultant(e) – Qualification/Validation d’équipements - H/F Job Opening In Lyon – Now Hiring Caduceum


Job description

Vos missions en tant que consultant :


En tant que Chargé(e) de qualification/validation, vous interviendrez chez notre client dans le respect des réglementations et des procédures qualité en vigueur et pourrez être amené à :



  • Revoir et/ou approuver des stratégies de qualification/validation pour les installations / équipements de production / utilités / HVAC / Salles blanches / Process…

  • Revoir et/ou approuver les documents techniques : plan directeur de qualification/validation, protocoles, fiches de tests, rapports, …

  • En collaboration avec le correspondant Qualification/Validation, assurer le suivi et la coordination des différentes phases de qualification (FAT/SAT/QI/QO/QP)

  • Participer aux différents tests si nécessaire

  • Contribuer et revoir/approuver des investigations des non-conformités et des actions associées

  • Revoir et/ou approuver l’analyse des résultats et la conclusion quant au statut qualifié/validé


 


Profil recherché :


De formation pharmacien, ingénieur ou universitaire Bac +5, vous justifiez d’une expérience significative en qualification / validation, vous ayant permis d’acquérir les compétences suivantes :



  • Maîtrise des FAT/SAT/QI/QO/QP

  • Maîtrise de la validation des procédés (fabrication répartition conditionnement à minima)

  • Rédaction des protocoles et rapports

  • Rédaction des fiches de tests

  • Gestion des non-conformités et plan d’action associée

  • Vous maîtrisez les exigences réglementaires associées (GMP/BPF, ISO 13485…) et les normes en vigueur

  • Vous êtes adaptable, curieux (se), rigoureux (se) et êtes doté(e) d’un bon relationnel


Required Skill Profession

Business Operations Specialists


  • Job Details

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