Consulente en Data Integrity

il y a 4 semaines


Paris, Île-de-France Agate IT Temps plein
Description du posteMissions principales
  1. Evaluation et amélioration des systèmes de gestion des données pour garantir leur intégrité et leur conformité aux normes réglementaires (GMP, GAMP, FDA 21 CFR Part 11, etc.).
  2. Développement et mise en œuvre des politiques, des procédures et des formations en matière d'intégrité des données.
  3. Réalisation d'audits internes et externes pour identifier les lacunes en matière de data integrity et proposer des plans d'action correctifs.
  4. Collaboration avec les équipes de qualité, d'informatique, de production et de laboratoire pour assurer une gestion cohérente et sécurisée des données.
Présentation du candidat idéal
  1. Diplôme en sciences de la vie, informatique, ingénierie ou domaine connexe.
  2. Expérience significative en gestion de l'intégrité des données dans l'industrie pharmaceutique.
  3. Connaissance approfondie des réglementations en matière de data integrity (FDA 21 CFR Part 11, EU GMP Annex 11, etc.).
  4. Expérience en validation de systèmes informatisés et en gestion de projets de conformité.

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