IT Compliance Officer

  • Location: Mont-Saint-Guibert
  • Type: Perm
  • Job #13970


IT Compliance Officer (Computer System Validation)

Position Purpose

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

Qualifications and 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 
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!