Pharma Validation Test Lead Job in Growel Softech
Pharma Validation Test Lead
Growel Softech
4+ weeks ago
- Navi Mumbai, Thane, Maharashtra
- Not Disclosed
- Full-time
Job Summary
JD
Should have worked on Life Science Computer System Validation, Risk Based Validation Approach
Good experience in GxP Verification and Validation
Should have experience in creating Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis
Should have good hands on validation testing experience including leading and defining Validation Strategy
Should be able to independently manage validation lifecycle of projects with minimum supervision
Knowledge of 21 CFR Part 11 for Electronic Records and Electronic Signatures
Good experience with SDLC and STLC
Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems.
Should have extensive exposure to Change Management process.
Extensive Domain knowledge of Life Sciences/ Pharma domain.
Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints.
Good understanding of ITIL process.
Involved in direct client interaction.
Competent in conflict management and escalation handling
Roles and Responsibilities
Validation TesterJD
Should have worked on Life Science Computer System Validation, Risk Based Validation Approach
Good experience in GxP Verification and Validation
Should have experience in creating Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis
Should have good hands on validation testing experience including leading and defining Validation Strategy
Should be able to independently manage validation lifecycle of projects with minimum supervision
Knowledge of 21 CFR Part 11 for Electronic Records and Electronic Signatures
Good experience with SDLC and STLC
Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems.
Should have extensive exposure to Change Management process.
Extensive Domain knowledge of Life Sciences/ Pharma domain.
Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints.
Good understanding of ITIL process.
Involved in direct client interaction.
Competent in conflict management and escalation handling
Experience Required :
8 to 10 Years
Vacancy :
2 - 4 Hires
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