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 environment.
- 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)
🏢 NR Consulting
📍 Noida