Junior Computer System Validation Consultant

Our Client is currently looking for a Junior Computer System Validation Consultant for a 6 Month contract based in Mont-Saint-Guibert, Belgium.

Role Summary:
Support computer system validation and qualification through its development life cycle and according to relevant policies, procedures and standards.

Key Responsibilities/Deliverables:
- Support the IT Risk and Compliance manager in reviewing system documentation through the system life cycle (eg validation plans, risk assessments, user requirements and functional specifications, test protocols and executed test protocols during design, infrastructure, operational and performance qualification phases).
- Follow-up delivery of system documentation and report progress to his/her manager.
- Document and follow-up IT deviations and CAPAs.
- Provide trainings on computer system validation.
- Provide advices to his/her manager on computer system validation process improvement.
- Assist during audit and participate to inspection readiness program.
- Assist in the evaluation of IT risks.

Knowledge, Skills and Experience:

Knowledge/skills
- Good knowledge of IT processes and the IT validation model (eg GAMP).
- Basic understanding of general information systems risks and controls.
- Basic understanding of Pharmaceutical (GMP/GCP/GLP) and/or Financial (Sarbanes-Oxley) regulations.
- Good problem solving, conflict resolution, communication and writing skills.
- Fluent in English (written and verbal). Knowledge of French is an asset.

Experience
- Minimum 6 months' work experience in computer system validation/qualification or IT Quality Assurance.

Education, Qualifications:
- Master degree in 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.