Computer System Validation (CSV) Specialist / Analyst

Cerebra; Dadri, Gurugram District, Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Cerebra is seeking a CSV Specialist to lead Computer System Validation activities for MNC clients. The role requires 6–8 years of experience and deep knowledge of CSV, CSA, GxP, and regulatory frameworks.

Location options include Gurugram, Bangalore, or Noida. You will plan, execute, and review validation deliverables, support audits and inspections, manage changes, and guide project teams on validation approaches to ensure systems are fit for intended use.

Qualifications

• Experience in Computer System Validation (CSV) and software qualification.
• Strong knowledge of GMP/ICH/GxP guidelines and 21 CFR Part 11 compliance.
• Experience preparing validation plans, URS, risk assessments, test protocols and traceability matrices.

Responsibilities

• Plan, execute and maintain CSV activities.
• Prepare and review validation documentation.
• Ensure systems are fit for intended use and compliant with regulatory requirements.
• Apply risk-based validation principles and manage validation deliverables.

Skills

Computer System Validation

CSV

21 CFR Part 11

GxP

ISO 13485

GAMP

ICH Q9

ICH Q8

SDLC

Validation Plans

URS

Risk Assessments

Test Protocols

Test Scripts

Traceability Matrix

Validation Summary Reports

Change Control

Configuration Management

Job description

Immediate /Short Notice Only - Cerebra Payroll - MNC Client

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.