• Monitored as an Implementation QA Manager on the Smart Data Quality (SDQ) product for the US and European clients (AbbVie, Merck & Co., Pfizer, AstraZeneca, & PPD, Inc.). The project aims to shorten the distance from lab to life (Clinical Trial: Accelerate the Data Review Processes).• Developed, reviewed, and implemented Standard Operating Procedures (SOPs) across the departments, ensuring alignment with industry standards and regulatory requirements. Conducted internal audits to assess compliance with the respective SOPs.• Subject Matter Expert (SME) in Medidata RAVE and Veeva Vault EDC tools for the edit-check requirements related to the test data entry and test data availability verification activities for the clinical trial data validation.• Performed and oversaw the edit-check test execution for assessing generated predictions (discrepancies) and handling end-to-end implementation QA activities for complete study delivery with high quality.• Presented a daily, weekly, or monthly QA status report, validation plan, test execution, and defect summary report to the stakeholders.• Experienced in effort and resource estimation for the QA activities in the respective project/account.• Involved in incident and defect management by assigning, tracking, resolving incidents, and leading them to closure by discussing with cross-functional teams and clients. Identified and highlighted the potential risks with stakeholders to mitigate them effectively.• Ensured compliance with the regulatory guidelines and CDISC standards, including US FDA and ICH-GCP, throughout the clinical data management process.

Led QA team, held meetings with stakeholders to update the status, managed internally with different teams for issues resolution, Requirement gathering, Analysis, Design discussions, Installation, Client escalations & issues with End-to-End Testing, Implementation & Configuration of the ARISg, LSRA & LSMV applications (Drug/Patient safety systems). • Thorough knowledge of 21 CFR Part 11, GxP and GAMP 5, EU Annex 11. Expertise in reviewing, correcting and providing the pre and post approvals for the IQ/OQ/PQ scripts. Excellence in generating, evaluating and executing IQ, OQ and PQ documents (CSV specialist) and actively involved in audit/inspection meetings. Creation and customization of the Adhoc/weekly/monthly/quarterly/annual reports (CIOMS, PSUR and DSUR) as per the client business requirements. Experienced in Adverse Events case creation, processing & successful submission to the respective regulatory agencies (E2B R2/ R3 format). Good exposure in Agile methodology & its concepts. Client Interactions to resolve Project related (L3 support) issues/Escalations.

Participated in Analysis, Designing, Installation, Configuration & Implementation of the Sterling Commerce solutions. Good experience in testing the IBM Sterling B2B Services Reporting & Analytics. End to End Testing of IBM DataStage ETL tool (Database, ETL, DW, DM & BI Testing). Worked on automation scripts by using ANT for API environment. Excellent working knowledge of BO/Cognos reports & ETL

Responsible for designing the test scenarios and test cases along with test execution activities for the Xerox Centre-Ware Internet Services (CWIS is an Embedded Web based printer management tool), CA Unicenter NSM (R 3.1 & R 11.1), NDPS (Novell’s NetWare Administrator tool Novell Distributed Print Services) & Microsoft SCOM 2007 applications