Description
Ensure that IT systems comply with standards (eg GxP, Sarbanes-Oxley, Privacy) throughout the system life cycle.
Primary 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 life cycle.
Assist during audit and participate to inspection readiness program.
Assist in the evaluation of IT risks.
Experience, Knowledge & Soft Skill Requirements
Required Experience & Knowledge
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 (eg ITIL), the IT validation model (eg 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
Education, Methodology & Certification Requirements
Master degree in IT, sciences or engineering. Other degrees are acceptable with appropriate education, training and/or experience indicating a sound understanding of computerized information systems and business processes.
Certification in computer system validation or equivalent is a plus.
Language Proficiency Requirements
English
Fluent (written and verbal)
French