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...