Contractor

6 months ago

Hinjawadi Pune Maharashtra, India BirlaSoft Full time

Country/Region: IN- Requisition ID: 7499- Work Model:
- Position Type:
- Salary Range:
- Location: INDIA - PUNE - BIRLASOFT OFFICE - HINJAWADI**Title**:Contractor**:

- Description:

- JD is as below:

- 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.

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