IT Compliance Consultant

  • Location: Mont-Saint-Guibert
  • Type: Contracting
  • Job #13972

 

 

IT Compliance Consultant

Position Purpose

The IT compliance consultant audits CCSM IT systems and software for compliance against GxP, US and EU regulations.

Key Tasks and Responsibilities

  • Update the inventory of IT systems and software and their interconnections
  • Check each system and the overall system for GxP compliance
  • Check each system and the overall system for EU and US regulations compliance
  • Propose and write the related quality events and Change Controls
  • Propose solutions for the recurrent and one shot qualification strategy for computerized systems
  • Write high-level data integrity assessments
  • Propose improvements to computerized systems SOPs & policies
  • Function as compliance matter expert to the IT Compliance Lead 
  • Know, understand and comply with the company’s standard operation procedures and policies

Qualifications and Experience

Experience

  • having worked in an IT-related Quality department in an international GxP environment for at least 5 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 
  • a certification in software audits is welcome
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