Computerized System Validation
2 days ago
As a CSV Engineer, you will be working for our clients in the respect of the applicable regulations and quality procedures.
Main assignments:
- To be responsible for preparing and/or executing validation activities and documentation for Computerized Systems, under respected regulations or guidelines: 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5, Annex 11, etc.
- To create and modify validation documentation, including:
- User Requirements Specifications (URS)
- Criticality analysis and Risk Analysis
- Validation Plan and Report
- Protocols, Scripts and Reports for IQ, OQ, and PQ
- Reports which summarize the results of the test executions
- Execution of qualifications scripts and reporting Validation deviations
The required professional skills and experience are:
- Degree (or similar) in IT, Engineering or Science
- 2 years’ experience working in GxP environment would be a plus, beginners are accepted and trained
- 2 years’ experience working on CSV projects would be appreciated, beginners are accepted and trained
- Excellent written/verbal English language skills are required. Other languages (French/German/Spanish) would be a plus
- Strong organizational and project management skills
- Familiar with GxP compliance requirements (FDA, EMA, GAMP 5, 21 CFR Part 11, PICs, etc.)
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