iStorm - IT Compliance Officer

☞ iStorm

전망: 180

갱신일: 16-11-2025

위치: Luxembourg

범주: IT-소프트웨어 IT-하드웨어 / 네트워킹 정보 기술

산업:

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작업 내용

Organisation and department description

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.

Job description

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.

Profile

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

Offer

Permanent contract in a international company.
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마감 시간: 31-12-2025

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