Nikhil is a Consultant with the Life Science and Health Care Practice of Deloitte and has 4 years of experience in providing Computerized System Validation (CSV) services for pharmaceutical companies. Prior to Deloitte, he was providing consulting services for a leading pharmaceutical company based in Germany wherein he worked on validating multiple applications relating to Clinical Reporting Clinical Protocol Development and Pharmacovigilance.
He has knowledge of 21 CFR part 11, GxP regulations, and regulatory processes and possesses a firm understanding of validation and testing activities required in life sciences industry.
He has experience include analysis of user requirements, risk analysis of requirements, development of validation/Test plan, validation/Test summary report, test protocol, test defect summary report, exit criteria determination, test objectives, tasks and
...Nikhil is a Consultant with the Life Science and Health Care Practice of Deloitte and has 4 years of experience in providing Computerized System Validation (CSV) services for pharmaceutical companies. Prior to Deloitte, he was providing consulting services for a leading pharmaceutical company based in Germany wherein he worked on validating multiple applications relating to Clinical Reporting Clinical Protocol Development and Pharmacovigilance.
He has knowledge of 21 CFR part 11, GxP regulations, and regulatory processes and possesses a firm understanding of validation and testing activities required in life sciences industry.
He has experience include analysis of user requirements, risk analysis of requirements, development of validation/Test plan, validation/Test summary report, test protocol, test defect summary report, exit criteria determination, test objectives, tasks and scenarios, data mining for creation of appropriate aggregate data, change management, regression analysis and managing offshore teams and has received a 90% customer satisfaction index for all the projects managed.
