Bharanitharan Rajendran

Computer System Validation(CSV) Consultant to leading pharma industry for GAMP5 CAT systems, with ICH QMS as applicable. Understand and adhere to the Quality manual, SOP on Project Management, Change Management, Document Management, Risk Management and Quality Management

+ Planning & implementation of validation processes on the applications per GAMP, FDA 21 CFR Part-11, Annex-11 regulations + Author the Validation Deliverables such as Validation Plan, Test Plan, Validation Summary and Test Summary Reports + Review and approve the Validation Deliverables such as User Requirements, System Requirements, Interface Requirements, System Design Specifications, Test Scripts, Test Executions, Test Incidents, Requirement Traceability Matrix and Change Controls, Defect Management

SPOC on driving multiple projects on validation perspective, deriving project time-line plan & successful closure on projects as committed without any compromise on quality and compliance with client satisfaction & appreciation on all the projects. Computer System Validation with GDP, GTP, Risk, Change & Defect Management. Review/Approve validation deliverables i.e., Test cases, executions, defects, FCCC assessments, URS, SRS, IRS and RTM. Authoring Test plan, Test summary and Validation summary report.