Job Directory Validation Lead

Validation Lead
Cambridge, MA

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Job Description

* Should have worked on Life Science Computer System Validation, Risk Based Validation Approach
* 21 CFR Part 11 for Electronic Records and Electronic Signatures
* SDLC and STLC, Verification and Validation
* Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems.
* &nb sp; 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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