Job Description – Computer System Validation Specialist
Domain: Life Sciences
Location: Brussels, Belgium (minimum 3 days onsite per week)
Contract Duration: 1 year
Language Requirements:
* French proficiency is mandatory for at least two subcontractors.
* English proficiency is mandatory for other resources.
Roles and Responsibilities:
* Validate IT systems implemented by our life sciences client, ensuring compliance with regulatory requirements.
* Define and manage the Project Documentation List in alignment with project timelines and milestones.
* Author critical validation documents, including:
* Validation Plan (VP)
* Validation Report (VR)
* Data Migration Plan and Data Migration Report
* Review key system deliverables such as:
* User Requirements Specification (URS)
* Functional Specification (FS)
* Configuration/Design Specification (CS/DS)
* Installation Qualification (IQ)
* Operational Qualification (OQ)
* Performance Qualification (PQ)
* Functional Risk Assessment (FRA)
* Test Strategy Plan and Test Reports
* Oversee and ensure controlled execution of data migration activities.
* Support ongoing operational activities such as:
* Change Management
* Deviation Management
* Periodic System Reviews
* System Retirement Procedures
* Preparation for Audits and Inspections
* Ensure strict adherence to stage gates and milestones as per the client’s project management methodology.
* Provide regular project updates and status reports to the management team.
* Identify and escalate system validation or operational risks, issues, and challenges in a timely manner.
Mandatory Skills:
* Strong expertise in Computer System Validation (CSV) in regulated environments.
Desired Skills:
* Deep knowledge of the Software Development Life Cycle (SDLC).
* Excellent communication and documentation skills.
* Team management and leadership capabilities.