Required Skills: Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis

Job Description

1.  Must have 10 - 14 years of experience
2. Should have worked on Life Science Computer System Validation, Risk Based Validation Approach
3. Good experience in GxP Verification and Validation
4. Should have experience in creating Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis
5. Should have good hands-on validation testing experience including leading and defining Validation Strategy
6. Should be able to independently manage validation lifecycle of projects with minimum supervision
7. Knowledge of 21 CFR Part 11 for Electronic Records and Electronic Signatures
8. Good experience with SDLC and STLC
9. Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems.
10. Should have extensive exposure to Change Management process.
11. Extensive Domain knowledge of Life Sciences/ Pharma domain.
12. Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints.
13. Good understanding of ITIL process.
14. Involved in direct client interaction.