Veena Kumar

• Strong experience in Project Management and in Computer System Validation • Expertise in Computer System Validation by following Validation Life Cycle and Software Development Life Cycle (SDLC) • Knowledge in Quality system and standard 21 CFR Part 11 • Expertise in writing of validation Documents such as Validation Plan, Qualification Plan, Test Plan, Test summary report, Validation Summary report. • Experience with Corrective Action and Preventive Action (CAPA) investigation to identify and evaluate the problem or non-conformance. • Experience in revising and reviewing Standard Operating Procedures (SOPs) for various business process in meeting with cross functional teams. • Hands on experience in HPQC, HPALM covered essential aspects of test management, aid in Lifecycle management in the testing process. • Excellent experience working with Document Management Tool and Agile methodologies. • Global delivery: Proven expertise in delivery of projects to clients in countries like India, Japan, Norway and USA. • Highly adept in managing issues and mitigating risk, governance standards, processes, schedules, financials, methodologies, and matrices.