CSV Engineer- 12 months FTC
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Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.
We have an exciting opportunity for a Computer Systems Validation Engineer to join Norgine in Hengoed.
The Role:
In this role, you will help ensure that Norgine’s GxP-regulated computerised systems, equipment, validation documentation and associated processes meet applicable quality and regulatory requirements. You will provide practical validation expertise throughout the system lifecycle and apply risk-based principles to support compliance, data integrity and operational effectiveness.
This is a 12-month fixed-term contract (FTC) role
Requirements
Key Responsibilities:
- Plan, coordinate and carry out validation activities for new and existing GxP-regulated computerised systems.
- Develop, review and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
- Perform system testing and verification to confirm that systems meet defined business, quality and regulatory requirements.
- Support audits, inspections and regulatory enquiries