Cerebra
Computer System Validation (CSV) Specialist / Analyst
1 month ago
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Important information
Contract type:
Permanent
Location:
Bengaluru, Karnataka, India
Work mode:
Onsite
Published on:
11 September 2026
What they need
Immediate /Short Notice Only - Cerebra Payroll - MNC Client
[email protected]
Only Whatsapp: 8977020346
Computer System Validation (CSV) Specialist / Analyst
Experience: 6 TO 8 years
Location: Gurguram / Bangalore / Noida
Mandatory Skills:
Computer System Validation, CSV, Computer Software Assurance, CSA, GxP, 21 CFR Part 11, ISO 13485, GAMP, ICH Q9, ICH Q8, SDLC, QMS, Risk Management, Validation Plans, URS, Risk Assessments, Test Protocols, Test Scripts, Traceability Matrix, Validation Summary Reports, Change Control, Configuration Management
Responsibilities:
- Plan, execute and maintain CSV activities.
- Prepare/review validation documentation.
- Ensure systems are fit for intended use.
- Apply risk-based validation principles.
- Support audits and inspections.
- Assess validation impact of system changes.
- Support revalidation activities.
- Manage change and configuration control.
- Maintain system inventory and validation status.
- Review and approve validation deliverables.
- Guide project teams on validation approaches.
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