Description
We are looking for a
Computer System Validation (CSV) Consultant (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Geneva
Branch: Wettbewerber
Your tasks:
- Execute several CSV projects in accordance with the clients' global IT/Quality standards, and industry standards (GAMP 5, EU Annex 11, 21 CFR 11) within the medical device department (types of systems include test equipment acquisition systems, automated software testing tools, software configuration/testing/deployment management tools)
- Write validation plan, URS, FS, risk assessment, obtain approval from system owner and QA
- Write IQ/OQ/PQ protocols, reports, VSR
- Execute testing in collaboration with local validation team
- Write applicable SOPs and training documents
Your qualifications
- Experience in the medical device industry
- Experience in computer system validation
- Solid documentation skills
- Experience in working with GAMP 5
- Knowledge of cloud hosting, data integrity
Skills:
- Compliance manager
Keywords: Compliance Manager