For our client, an international company in the area of Louvain-la-Neuve, we are looking for a "IT Compliance Officer" for computer system validation. 
The IT compliance lead coaches and drives improvement in the IT team from a quality and compliance perspective. 

• 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.

Experience

• 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 

- Permanent contract in a international company.