Function information
Introduction
We are looking for an IT Compliance Specialist for a mission in Wavre, freelance missions long term.
Mission
Ensure that IT systems comply with standards (e.g. GxP, Sarbanes-Oxley, Privacy) throughout the system lifecycle.
Tasks & Responsibilities
• Identify IT compliance controls that comply with standards
• Verify that IT compliance controls are tested successfully prior system release
• Ensure that fit-for-purpose project documentation (if relevant) is delivered according to quality standards
• Provide advices on compliance control identification, testing and monitoring process improvement
• Act as a IT compliance point of contact during the system lifecycle
• Assist during audit and participate to inspection readiness program
• Assist in the evaluation of IT risks
Skills Requirements
• Excellent problem solving, stakeholder management, conflict resolution, communication and writing skills
• Excellent organizational skills with ability to think proactively and prioritize work
• Good understanding of IT processes (e.g. ITIL), the IT validation model (e.g. GAMP), key regulated business processes and information system risks and controls
• Good understanding of Pharmaceutical (GMP/GCP/GLP) regulations is an asset
• Good professional experience in computer system validation/qualification, IT Quality Assurance, IT audits or IT compliance assessments
• SAP knowledge is a plus
• General knowledge of IT infrastructure
• Good experience in pharmaceutical environment
• Master degree in IT, sciences or engineering or similar by experience
• Certification in computer system validation or equivalent is a plus
Language
• English: fluent
• French: good
Offer
Are you in for a change? We’re more than happy to offer you:
• interesting projects that boost your experience and spark your interests
• follow-up by a Modis Talent Manager who looks after your needs
• a warm welcome and a fun team that will accompany you to awesome social and business events
• daily rate in accordance to your experience