Job Description 1. Plan and own end to end Validation of enterprise level system implementations and their upgrades 2. Be the primary for Business and Technical teams on Validation strategy and implementation 3. Define Validation Master Plan, Validation Strategy and coordinate for IQ, OQ and PQ. 4. Perform Risk Analysis , Quality Planning, Deliverable life cycle Management, as well as be the focal point of all validation management activities 5. Manage and own validation testing including leading and defining GxP testing Strategy 6. Educate different groups on GxP processes during project execution including alignment with SOPs and the processes to be followed 7. Work on Testing strategy with co-locatedremote teams and follow STLC lifecycle to ensure testing is completed as per processes 8. Coordinate with Quality ControlAssurance to ensure adherence to corporate and regulatory standards Should have worked on Life Science Computer System Validation, Risk Based Validation Approach bull Should have experience in creating Validation Master Plan, Validation Strategy, IQ, OQ and PQ. bull Should have good hands on validation testing experience including leading and defining Validation Strategy bull 21 CFR Part 11 for Electronic Records and Electronic Signatures bull Good experience with SDLC and STLC bull Extensive experience in Verification and Validation bull Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems. bull Should have extensive exposure to Change Management process. bull Extensive Domain knowledge of Life Sciences Pharma domain. bull Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints.