Validation Lead

Exp: 8 to 12 Years

Location : Bangalore/ Hyderabad

NP: Immediate/30 days

Job Description :

Validation Lead should ensure all processes, and IT systems consistently meet safety and quality standards. They manage the IQ/OQ/PQ lifecycle and perform risk assessments to maintain strict regulatory compliance with agencies like the FDA. Ultimately, they serve as the primary expert during audits, providing the documented proof required to guarantee patient safety and product integrity.

1. Validation Strategy & Governance (7+ Years) - Develop and maintain Validation Master Plans (VMP) and lead risk-based validation strategies aligned with regulatory requirements, business objectives, and project timelines for computerized systems (CSV) and processes.

2. Validation Execution & Documentation (7+ Years) - Author, review, and approve validation lifecycle documentation including URS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, test scripts, and validation summary reports for systems, equipment, processes, and clinical/usability validation activities.

3. Compliance & Audit Readiness (7+ Years) - Ensure compliance with GxP, 21 CFR Part 11, CSA, and Data Integrity requirements while partnering with QA teams to support audit readiness, inspection preparedness, deviation/CAPA management, and validation compliance across systems, utilities, and methods.

4. Testing & Validation Expertise (78+ Years)- Drive testing and validation activities for medium to large-scale implementations including SaaS and Cloud-based systems using Waterfall, Agile, and Iterative methodologies with strong focus on risk-based testing and CSV best practices.

5. Leadership & Cross-Functional Collaboration (3+ Years in Leadership Role) - Lead, mentor, and collaborate with validation teams, business stakeholders, QA, IT teams, vendors, and external partners to ensure high-quality deliverables, stakeholder alignment, and successful project execution within timelines.