Csv Validation Engineer

2 weeks ago

Singapore VALINA SERVICES PTE. LTD. Full time

As a Consultant, you will be working for our client in the respect of the applicable regulations and quality procedures and could be required to:
Main Responsabilities:

- Be responsible for preparing and executing test documentation for computerized systems. You should have excellent understanding of 21 CFR Part 11, 21 CFR Part 820, ISO 13485, and GAMP 5 methodologies.
- Create and modify validation documentation including:

- User Requirements Specifications (URS)
- Criticality analysis and Risk Analysis
- CSV plan and protocols (IQ, OQ, PQ)
- Reports which summarize the results of the test executions
- Exception reports which identify defects or issues during test execution

Professional skills and experience:

- Degree (or similar) in IT, Engineering or Science.
- 2+ years’ experience working in GxP environment.
- 2+ years’ experience working on CSV projects.
- Excellent written and verbal communication skills.
- Strong organizational and project management skills.
- Familiar with compliance requirements (FDA, EMA, GxP, GAMP 5, 21 CFR Part 11, PICs, etc.).

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