Title: Life Sciences : Computer System Validation

Location: Gurugram, Bangalore, Noida

Exp: 6+ Yrs

Job Description:
Key Responsibilities
Plan, execute, and maintain Computer System Validation (CSV) activities for GxP-relevant computerized systems.
Develop and review validation deliverables including Validation Plans, User Requirements, Risk Assessments, Test Protocols, Test Scripts, Traceability Matrices, and Validation Summary Reports.
Ensure validation activities demonstrate that systems are fit for intended use, reliable, and operating within a controlled setting.
Apply risk-based validation principles aligned with regulatory expectations such as GxP, 21 CFR Part 11, and ISO 13485.
Support audits and inspections by providing complete, explicit, and compliant validation documentation.
Assess the impact of system changes and support revalidation activities when required.
Ensure validated systems remain in a compliant state through effective change control and configuration management.
Review system updates, patches,



and enhancements to determine their validation impact.
Maintain system inventory and validation status throughout the system lifecycle.
Work closely with IT, Quality, Engineering, Vendors, and Business stakeholders to support validation activities.
Participate in system implementation projects and ensure validation requirements are incorporated from the early lifecycle stages.
Provide training and awareness on CSV processes and regulatory expectations.
Provide consultation to project teams on appropriate software validation approaches.
Recommend suitable validation approaches based on project requirements and selected software validation methodology.
Guide project teams in creating validation deliverables, SOPs, and Work Instructions.
Provide consultation on regulatory compliance requirements including PI/PHI and Electronic Records and Electronic Signatures (21 CFR Part 11).
Provide consultation on software change m

📌 Life Sciences Noida (India)
🏢 NR Consulting
📍 India