Posizione: Associate

Tipo di lavoro: Full-time

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Contenuto del lavoro

Data integrity assessment has been conducted on each computerized system of our company. From this DIRA project, a list of DI Gaps has been observed and should be resolved to be in line with the Global Data Integrity Standard. A Data Integrity CAPA Plan has been built to ensure a follow-up on this.

To works on this DI Gaps CAPA PLAN experience below is required:

  • Understand and have probative experience in Data Integrity principle
  • Understand Software administration (user access, profile, network file extraction, network access, Audit trail, logs and reporting…)
  • Find and propose solution to resolve the DI gap observed in different system (Lab’s system, production system Excel file…)
  • Be able to prepare, plan and implement the DI Solution approved as a small project.
  • Prepare training support (presentation, video) and train end-user once the gap has been resolved to the eventual change implemented.
  • Write qualification/validation documents activities depending on gaps resolution implemented.
  • Write quality documentation process (SOP, Form, Logbook...) to ensure the future process to implement.
  • Follow-up the data integrity project activities (CAPA PLAN) by a regular up to date of the project support document.
  • Performs audit trail´s data integrity risk assessments as per current policies once required on new system discovered.
  • Act as OT Quality Specialist (SME and Quality point of contact) during project implementation/ Audit observation.
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Scadenza: 10-01-2026

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