Description
Computer System Validation (CSV) Consultant (IT Risk & Compliance) - French & English Speaking - Brussels, Belgium.
Start: 15th June.
12 Month Contract.
My client in Brussels, Belgium is looking for a Computer System Validation Consultant (IT Risk & Compliance) to support computer system validation and qualification through its development life cycle and according to relevant client policies, procedures and standards.
Key Responsibilities/Deliverables:
* Support the IT Risk & 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 client during audit and participate to inspection readiness program.
* Assist client in the evaluation of IT risks.
Knowledge, Skills and Experience:
* Strong knowledge of IT processes and the IT validation model (eg GAMP).
* Good understanding of key regulated business processes.
* Good understanding of general information systems risks and controls.
* Familiar with Pharmaceutical (GMP/GCP/GLP) and/or Financial (Sarbanes-Oxley) regulations.
* Stakeholder management and issue and risk management skills.
* Excellent risk mitigation, problem solving, conflict resolution and communication skills.
* Fluent in English and French
* SAP knowledge is a plus.
Start: 15th June 2015.
12 Month Contract.
Location: Brussels, Belgium.