Sr.Validation/ SDLC Lead
8K Miles Software Services, Inc.
This is a Contract position in New Brunswick, NJ posted April 16, 2020.
Sr.
CSV Validation SDLC Lead JD Currently working with Clinical Operationsrsquo group for validating multiple modules of Medidata suite of products, SHARP and Pinnacle enterprise software.
bull Lead the activities related to validation effort for SaaS applications ensure compliance to internal procedures, 21 CFR Part 11, GxP regulations for various modules of Medidata and Pinnacle enterprise application.
bull Create, Review Compliance Analysis, Compliance Plan, Architecture Design, Test Plan, Test Scripts, and Compliance Reports.
bull Support risk based validation, advise on regulatory gaps and adherence to internal SOPs.
bull Support Change Control and periodic releases for Medidata Rave, Patient Cloud, iMedidata, Coder, Balance and Safety Gateway.
bull Develop Impact Analysis to evaluate changes and upgrades to Medidata applications.
Review documentation from quality perspective and ensure successful completion, approvals of deliverables per internal SDLC.
