Majority of experience in Life Sciences domain involving Case Processing, Pharmacovigilance and validating systems in ArisGlobal; Individual contributor collaborating with distributed teams, engaged in Computer System Validation, being agile and hands on automation, responsible for the quality of deliverables.Professional Experience:Employee of Infosys from 1.5 years working for Novartis customer in the role of Program Quality ManagerWorked with ArisGlobal for 11+ years for AE, Regulatory product suites• AE case processing business workflows for Boehringer Ingelheim (BI)• GAMP5 practiced and validated as part of PV products• Practiced 21CFR Part 11 norms during product validations• Good in case submission, reporting using E2B R2 and compliance• IQ and OQ for BI and Pfizer customers• Performance Qualification (PQ) for several major ARISg releases• Handling Change Requests, evaluations and Approvals• Excelled in professional services for customer LEO for implementation and support• Auditee for vendor audits in ArisGlobal for Novo Nordisk• Conducted User Acceptance testing and carried out validations at CTI,USA• Automated validation tests using Selenium-Java scripts• Thorough understanding and usage of various RDBMS concepts, writing simple to complex queries• Project, test management using JIRA tool
Listed skills include Big Data Testing, Map Reduce, Sqoop, Hadoop Mapreduce, and 9 others.