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Validation de Systu00e8mes Informatisués – VSI (H/F) Job Opening In Manche – Now Hiring NEO2


Job description

Validation de Systèmes Informatisés - VSI (H/F)

Dans le cadre du renforcement de la conformité réglementaire de ses activités, notre client, acteur majeur de l'industrie médicale, souhaite renforcer son équipe qualité.

La mission porte sur la validation de l'ensemble des systèmes informatisés, en lien avec les exigences qualité.

- Réaliser l'analyse d'impact réglementaire des systèmes informatisés existants et nouveaux.

- Rédiger et mettre à jour l'ensemble de la documentation qualité associée (Plan de Validation, URS, Risk Assessment, Protocoles IQ/OQ/PQ, rapports de validation).

- Piloter les activités de qualification des systèmes et assurer la traçabilité documentaire.

- Accompagner les équipes métiers et IT dans les bonnes pratiques de validation.

- Participer aux audits internes et inspections réglementaires

- Assurer un reporting régulier auprès de la direction Qualité

- Apporter un support à la mise en conformité continue et à l'amélioration des processus VSI.

Required Skill Profession

Computer Occupations


  • Job Details

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