Immediate /Short Notice Only - Cerebra Payroll - MNC Client [email protected]

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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.

📌 Computer System Validation (CSV) Specialist / Analyst (Bengaluru)
🏢 Cerebra
📍 Bengaluru