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Urgent! Expert validation Systèmes Informatisés (CS Expert) (F/H/X) Job Opening In Martillac – Now Hiring AbbVie

Expert validation Systèmes Informatisés (CS Expert) (F/H/X)



Job description

Description du poste

Au sein du Département Qualification / Validation SI, vous êtes un référent expert en validation des systèmes informatisés (SI), responsable de la mise en place des stratégies de validation des systèmes informatisés requises pour les phases de développement, cliniques et commerciales.

Votre rôle sera principalement de gérer les projets de validation SI dans les délais impartis : réaliser les Analyses de Risques et définir les stratégies de validation ; rédiger et/ou revoir les documents relatifs aux SI (Plan de Validation, analyses de risques, protocoles/rapports de qualification et validation, procédures).

  • Vous suivrez et exécuterez les tests de qualification sur le terrain.
  • Vous serez autonome sur le suivi des déviations, CAPA et Change Control sur les qualifications des SI.
  • Vous serez garant de la stratégie Data Integrity pour les données électroniques sur le site de Martillac.
  • Vous identifierez les écarts par rapport aux standards et aux réglementations et identifier les actions de re-qualification en cas de correctif.
  • Vous participerez à la mise à jour de l’inventaire des SI, de leur statut et de la documentation associée (documentation technique, dossier de qualification).
  • Vous participerez à la définition des besoins utilisateurs via la revue et/ou participer aux rédactions des URS.
  • Vous piloterez le maintien du statut validé des SI via la revue périodique.
  • Vous aurez à créer et mettre à jour la documentation qualité liée à l’activité, et vous serez force de proposition pour l’amélioration continue du process de validation des SI : rédaction et mise à jour de documents, revue des processus, etc
  • Vous présenterez les stratégies de validation SI et les dossiers de validation lors des audits et inspections.

Qualifications

  • Bac+5 Ingénieur et/ou expérience (minimum 3 à 5 ans) en Validation des systèmes informatisés dans l’industrie pharmaceutique / Dispositif Médical / Biotechnologie.
  • Vous maîtrisez les exigences réglementaires (BPF/GMP, 21 CFR part 11, GAMP) ainsi que les exigences liées à l’intégrité des données (ALCOA).
  • Vous avez de bonnes connaissances sur l’infrastructure informatique et les process IT (processus de sauvegarde/restauration, Active Directory,…).
  • Vous avec des connaissances en microbiologie et en chimie, et sur les équipements de laboratoire et de production associés aux fabrications pharmaceutiques.
  • Vous avez l’esprit d’équipe et aimez collaborer en transverse.
  • Vous avez des compétences en anglais qui vous permettent de rédiger, présenter des documents et de travailler dans un contexte international.


Informations supplémentaires

AbbVie est un employeur garantissant l'égalité des chances et s'engage à agir avec intégrité, à stimuler l'innovation, à transformer des vies et à servir notre communauté.

Employeur garantissant l'égalité des chances pour les anciens combattants et les personnes en situation de handicap.


Required Skill Profession

Computer Occupations



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