CSV Analyst
CSV Analyst
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Review and validate vendor-provided system documentation for serialization/track & trace systems (e.g. Optel Systech Trace Link).
- Develop and execute a risk-based validation strategy aligned with company and regulatory standards.
- Create or refine UAT scripts execute UAT and track results to completion.
- Build and manage a comprehensive traceability matrix linking user requirements to test results.
- Deliver a fully validated document package for final review and sign-off by the CSG (Computer System Governance) group.
- Work independently to identify stakeholders obtain required documentation and manage communication across business units.
- Operate within a defined budget and scope delivering all validation artifacts as a fixed body of work.
- 7 years of experience in Computer System Validation (CSV) within regulated pharmaceutical or life sciences environments.
- Direct experience with serialization and track & trace systems ideally Optel Systech or Tradelink.
- Strong understanding of validation documentation lifecycle including VMP URS RTM UAT and summary reports.
Employment Type
Full Time
