Description
Computer Systems Validation EngineerLocation: Near Brussels
Salary: €500 per day
Contract: 12 months
My client is a global Pharmaceutical company who thanks to their recent expansion, are looking to bring on a talented CSV Engineer to join their team near Brussels, Belgium.
Responsibilities include:
- Ensuring business processes are designed to meet the requirements of relevant good practises (GxP)
- Support the RFP process, solution review and selection
- Validation activities supporting the implementation of a centralised Computer Aided Design (CAD)
- Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS)
- Validation activities supporting the implementation of a centralised Product Stewardship system
- Validation activities supporting the development and implementation of interfaces to/from other global systems (SAP, Data Warehouse, Ticketing System)
- Conducts Vendor Audits
- Regulatory considerations of Requirements, Systems, Processes and ensures Requirements are appropriately specified and testable
- Coordinates Business Criticality Risk Assessments
- Coordinate Supplier team through Risk Based compliance approach (Traceability Matrix and Risk Assessment)
- Develops Validation Plans and Test Protocols to define the approach to system verification
- Develops appropriate test scripts, review results, develop testing summary reports and release notes
- Must have extensive experience of Computer Systems Validation (to GAMP5) in the Pharmaceutical / Medical Device / Life Sciences industries
- Good understanding of US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards, GxP (GMP, GCP, GLP etc)
If this sounds like a role that suits your skill set and you would like to find out more, please get in touch with to kickstart the next stage of your career!