Kumar Sanku

About Kumar Sanku

At Covance, my focus as a Senior Validation Analyst has been on ensuring the integrity…

Experience

1. Sr Validation Analyst Qa Compliance Consultant

   Covance

   Oct 2018 — Present

   Analyzed the Business requirements and prepared the Validation Master Plan. Maintained 21 CFR Part 11 compliance for computer systems by conducting Risk Assessments, identifying compliance gaps, and developing Remediation Plans Developed the Electronic Records and Electronic Signatures Assessment document by performing Part11 assessment to the components involved in maintenance of Electronic Records, Electronic Signatures and Audit Trails in accordance with 21CFRPart11 regulations. Developed the User Requirements Specifications (URS), Functional Specifications (FRS) and the Design Specifications document (DS). Reviewed and updated end to end validation documentation for Track Wise to ensure compliance with company policies and procedures. Ensure documentation meets quality standards, regulatory compliance and company guidelines. Worked as TrackWise Administrator assigning logins, roles and giving permissions to access the software for the testing instance. Advised in the validation of EDMS, GxP Assessment database, and Change Management System. Developed, reviewed, validated and approved the Installation Qualification, Operational Qualification and Performance Qualification. Performed black box testing, positive testing, negative testing, front end testing and regression testing. Tracked, Investigated and resolved Bugs and defects Prepared Deviation Reports when the test criteria did not meet the acceptance criteria. Developed, Modified and reviews SOPs, Operating Manuals, SWPs, and User guides Developed the Validation Summary Report to provide a summary of the validation activities and executed deliverables. Conducted the QA training of the business team & QA Testers involved in test script execution.