Computer System validation Engineer
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Job Details
Skills
- Research and Development
- Computerized System Validation
- GxP
- GAMP
- Sarbanes-Oxley
- ISO 9000
- ITIL
- Inspection
- Auditing
- Corrective And Preventive Action
- Management
- SOP
- Regulatory Compliance
- URS
- Reporting
- Veeva
- Risk-based Testing
Summary
Hi,
Title:Computer System validation Engineer
Compute System Validation(CSV) with R&D Knowledge
Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
Knowledge, Experience and Skills:
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CORE CSV
21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
Authoring of URS/FS, protocols, final reports, validation plan/report
High-level understanding of Veeva Vault suits
Risk-based testing aligned to CSA fundamentals
- Dice Id: 91018020
- Position Id: PDT - 11873-13008-1786639796
- Posted 12 hours ago
Company Info
About Purple Drive Technologies LLC
Founded in 2007, Purple Drive started as a tech solutions firm and has grown into a full-service consulting and talent partner. We help businesses navigate complex technology challenges while connecting top professionals with career-defining opportunities.
We believe in transforming businesses through smart IT solutions and empowering technologists to grow their expertise through challenging projects and meaningful partnerships. Built on over 20 years of trusted relationships, we create success stories for both our clients and the talented professionals who drive innovation forward.
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