What You’ll Do:
- Lead and support Computer System Validation (CSV) activities across the full system lifecycle, including validation planning, risk assessments, testing strategies, execution oversight, and validation deliverables.
- Drive validation efforts for GxP-regulated applications, data migration projects, and infrastructure qualification activities to ensure compliance and operational readiness.
- Ensure computerized systems remain in a validated state through effective change management, periodic reviews, lifecycle management, and ongoing compliance monitoring.
- Partner with IT, Quality Assurance, Regulatory Affairs, business stakeholders, and vendors to deliver compliant, effective, and business-aligned technology solutions.
- Apply risk-based validation methodologies and industry best practices to optimize validation activities while maintaining regulatory compliance.
- Support governance and compliance for critical GxP systems, including system implementations, enhancements, upgrades, retirements, access reviews, backup verification, and disaster recovery testing.




- Review and approve system changes, ensuring appropriate validation impact assessments, testing requirements, and documentation standards are met.
- Oversee and collaborate with external service providers and implementation partners to ensure high-quality delivery of validation, testing, and support services.
- Develop, maintain, and enhance validation documentation, procedures, SOPs, training materials, dashboards, and compliance metrics to support inspection readiness.
- Identify and drive continuous improvement initiatives that strengthen IT Quality processes, increase operational efficiency, improve vendor performance, and support regulatory and business transformation programs.

What You Bring:
- Bachelor’s degree in Information Technology, Computer Science, Business Administration, or a related field.
- 4+ years of experience in IT Quality, Computer System Validation (CSV), IT Complian

📌 IT Quality Lead (India)
🏢 VB Spine
📍 India