• CSV and quality consultant for Acadia’s Quality systems • CSV process guidance to ongoing Quality Event, Change Management• Drive QMS enhancements initiatives.• Data Integrity Program: DI assessment of Business processes and R&D systems, Mitigation Planning and tracking the progress in coordination with IT and Business• Inspection Readiness: Participation in the mock inspections• Perform and assist project team in risk identification / assessment / categorization / mitigation and acceptance criteria etc.• Author, Review and Approve CSV deliverables.• Provide quality and CSV guidance to IT and Business, support to ad-hoc requests.

• Lead strategic validation program and projects across Otsuka domains; plan and perform validation lifecycle activities throughout its implementation and Change Management. • key COTS products implementations at Otsuka includes Oracle EBS, ComplianceWire, eLearn SuccessFactor, LabWare LIMS, eTMF, ServiceNow, Argus, Clinical trial data management system, Empower 3, LabX, Veeva PromoMats, Veeva CRM, Veeva InGenius, JReport, HP ALM and many other custom-built applications and portals. • Lead the project team by providing process, regulatory and quality guidance• Provide guidance in initial Regulatory / risk Assessments, GDPR, Cloud and Data Integrity Assessments• Assess Supplier Assessment Reports for identified gaps in vendor SLC/QMS and determine the impact on validation approach.• Perform and assist project team in performing functional risk assessment (FMEA and FTA techniques), risk identification, risk categorization, risk mitigation and acceptance criteria etc.• Author key Assessments and Validation deliverables i.e. Quality Risk Assessments, Validation Plan, Functional Risk Assessment, Validation Summary Report etc.• Review and Approve Validation Plans for validation strategy, dependencies, risk assessment and overall approach• Analyze and review the business requirements, User Requirements and Functional Requirements from GDP perspective. • Author and execute IQ / OQ / UAT / PQ protocols for new or existing systems, equipment or software in accordance with 21 CFR Part 11, GxP regulations and GDP guidelines• Method Validation for Lab systems; assistance provided to Lab Analysts• Review/monitor defect management for system deviations from reporting till closure• Assist project teams on System Support documentations (Training plan, System Support / Governance plan, disaster recovery, Business continuity, System Backup/Recovery plan etc.) • Participate in ‘Go/NoGo’ decisions• Perform Spreadsheet/Query Validation

• Testing and validation lead for Key projects implementations at Merck. It included RCAM (FirstDoc Documentum) implementation & Data Migration and Master Data Stewardship (MDS) program• Coordinate with project teams for Requirement Analysis and clarifications• Coordinate with offshore team for knowledge sharing and project specific guidance• Prepare Validation / Test Plan considering project dependencies, assumptions and scope• Develop, Review & execute SIT, OQ and PQ test scripts utilizing QA best practices and standards, Maintain traceability• Develop, Review & execute OQ test scripts following GxP guidelines, review of Test Results & Test Logs in Quality Center• Review Requirement Traceability and manage defect triage & closure• Author Validation Plan, Validation Summary / Test Report • Review system Validation deliverables

• Manage test and validation delivery for Abbott Vascular division projects i.e. Hyperion EssBase and LIMS Implementation. Engage with Implementation team and Business Analyst to understand the business requirements, and develop test/Validation strategy• Develop, Review & execute OQ test scripts following GxP guidelines, review of Test Results & Test Logs in Quality Center• Review Requirement Traceability and manage defect triage & closure• Author/ Review Validation Plan/ Validation Summary / Test Report

• Manage testing and validation for multiple Merck Europe and US projects/programs during this tenure • Key projects implementations at Merck included Global Master Data Management (Informatica ETL) – US/Itley Release, ORIOM, Cognos Reports, EMEA-Univadis Portal validation and Change Management• Coordinate with project teams for Requirement Analysis and clarifications• Coordinate with offshore team for knowledge sharing and project specific guidance• Prepare Validation / Test Plan considering project dependencies, assumptions and scope• Develop, Review & execute SIT test scripts utilizing QA best practices and standards, Maintain traceability• Develop, Review & execute OQ test scripts following GxP guidelines, review of Test Results & Test Logs in Quality Center• Review Requirement Traceability and manage defect triage & closure• Author Validation Plan, Validation Summary / Test Report • Review system Validation deliverables

Worked as Principal lead for Storage domain customer 'Iron Mountain' for their flagship product 'Connected Backup PC'. It is a software solution that protects you from PC and laptop data loss. Role for this assignment evolved from a developer to principle test lead.Key Activities...1) Played the role of QA lead for multiple releases of the product 2) Assisted team in design & execution of system & system integration test cases for Products’ modules 3) White box testing of Agent / BackupServer message protocols.4) Contributed as an overall Release Manager.5) Lead the triage meetings to discuss/decide the fate of change requests prior to market release6) Coordination with onsite project managers and do the follow up on open issues7) Coordination with development and support team to understand the release scope and then to identify regression scope8) Coordinated and planned out pre-production, smoke and release testing9) Performed smoke testing for quick identification of blocking issues

Neel Software team used to work on General Electrics (GE)'s 'Steel Plant process automation' software which was a real time application to automate steel plants. Neel software was one of the service providers to the client to help modify/ configure/ fine-tune the software for steel plants worldwide. I was one of the members of team which was involved in offline/online testing for two china based steel plants in a offline, simulated and online environments. I was also involved in a the development of web based application ‘Log Analyzer’ and MQ -series messaging application ‘APM-MQ’.