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Validation tester and leads
Ref No.: 16-11567
Location: CA, California
Validation tester and leads

We are looking for a Validation Test Lead. This is a client facing role & the candidate will have regular interactions with various client managers.


· years of Experience in Life Sciences, Computer System Validation and Testing

· Must possess hands-on experience in Trackwise

· Good understanding of FDA regulations, 21 CFR Part 11, GxP requirements along with knowledge of GAMP, GDP

· CSV (Computer System Validation) SOPs, SDLC and testing processes

· LS COTS products (Trackwise, Documentum, Veeva, LIMS, LMS, CTMS etc)

· Experience in Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report

· GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting

· Working with Test Management tools (Client ALM/Jira/Bugzilla)

· Performing estimations for Validation and Testing activities o Leading and managing testing and validation activities in synchronization with project scope, schedule and objective

· Experience in Daily/Weekly status reporting

· Risk Management & Timely Communication

· Must possess formal training/certification on Testing & Validation

· Excellent communication skills

· Should be able to work independently with minimum supervision

· Should have worked in cross-functional environments and comfortable to liaison with business