IT Compliance Officer

☞ Clinical Supplies Management Europe sa

Visualizza: 165

Giorno di aggiornamento: 26-11-2025

Località: Mont-Saint-Guibert Walloon Brabant

Categoria: IT - Software

Industria: Medical Practice

Posizione: Entry level

Tipo di lavoro: Full-time

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Contenuto del lavoro

Role

The IT compliance lead coaches and drives improvement in the IT team from a quality and compliance perspective.

Key Tasks And Responsibilities
  • Propose and implement improvements related to IT compliance
  • Write and monitor the Deviation and the CC (Change Control) process
  • Support validation / qualification strategy for computerized systems and write periodic evaluation reports for computerized systems
  • Support quality risk management computerized systems
  • Write and monitor data integrity assessments
  • Perform proper management of IT SOPs & policies, write and review of procedures
  • Document review/approval and report generation, as requested
  • Function as Quality department liaison and compliance matter expert to other department representatives, customers and regulatory representatives
  • Monitor and notify changes in IT-related GxP regulations and propose improvements
  • Cultivate integrated working relationships with employees and other departments to maintain and foster quality standards
  • Contribute to the IT department’s activities to ensure continuity of operations.
  • Know, understand and comply with the company’s standard operation procedures and policies
Experience

Requirements
  • having worked in an IT-related Quality department in a GxP environment for at least 2 years
  • able to apply GAMP5 “Risk based approach to compliant GxP computerized systems”
Hard Skills
  • knowledge (above average) of EU GMP, cGMP and ICH
  • basic quality techniques (Pdca, 6m, 5 Why, Kaizen, Pareto, Ishikawa,...)
  • compliance knowledge
  • good understanding of software, data integrity and IT systems
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Scadenza: 10-01-2026

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