Computer System Validation (CSV) Specialist / Analyst

Cerebra; Dadri; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cerebra is seeking an experienced CSV Specialist/Analyst for Noida to plan, execute, and maintain computer system validation activities across CSV projects. You will prepare validation documents, assess risk, and ensure systems comply with 21 CFR Part 11, ISO 13485, and other GxP requirements.

The role involves supporting audits, managing change and configuration control, and guiding project teams on validation approaches to ensure quality and compliance throughout the software lifecycle.

Qualifications

• Experience in planning, executing, and maintaining CSV activities.
• Prepare and review validation documentation.
• Ensure systems meet intended use and compliance.

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.

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

Job description

Immediate /Short Notice Only - Cerebra Payroll - MNC Client

Computer System Validation (CSV) Specialist / Analyst
Experience: 6 TO 8 years
Location: 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.