Summary

• Offers well over 10 years of industry experience with expertise in SDLC including business analysis, design, testing, verification, validation, software quality assurance, assessments, audits, software metrics, deployment, process definition implementation for critical business requirements
• A self-starter with clear understanding of the business needs & having goal oriented approach to problem solving. Possess excellent communication & motivation skills
• Successfully implemented Quality Management Processes, Software Change Control Processes as per ISO/CMMi(SEI V 1.2 Level 5) standards and regulatory standards including FDA, HL7, CENELAC, CFR Part 11, SOX, MHRA, GxPs, SOPs
• Successfully completed multiple assignments for clients like Merck, Bristol Myers Squibb, AstraZeneca Pharmaceuticals, Siemens Medical Solutions, Siemens VDO & Siemens Information Systems Ltd.
• Strong people-management and co-ordination skills, interfacing between Business Analysts, Requirements analysts and Product development groups, Adaptable to any technology/ process

• QAI, USA certified CSQA professional
• QAI, USA Trained Six- Sigma Green Belt champion
• TQMI certified Lead Auditor
• OBL- On Becoming Leader

• Expertise in SDLC- Software Test Life Cycle: test plan and test strategy, test case design/description document, review of test plan, test case design documents, test requirements, test drivers coding, bug tracking and metrics collection, defect analysis, implementation of corrective and preventive action
• Instrumental in process definition, training and implementation for AGILE SCRUM methodology across various organizations
• Defined and implemented the PRODUCT, SPRINT and RELEASE backlogs for all SCRUM teams
• Experience leading testing efforts, including experience with all phases of testing: System, Integration, User Acceptance & Performance (Load, Volume, Reliability, Stress, Supportability, Usability, Regression) Testing
• Well versed in Waterfall, V-Model, Spiral/Iterative/RAD (Rapid Application Development), Agile SCRUM and RUP (Rational Unified Process), Project Management Processes: Traditional (TPM), Adaptive (APF), Extreme (xPM) management processes
• Responsible for Design, documentation and implementation of complete bug reporting/tracking flow chart
• Instrumental in definition and implementation of quality assurance processes across the organizations with 100% ROI {return on investment}- Processes include requirements management, design, coding, code review, unit testing, defect analysis, corrective and preventive action
• Responsible for top-down approach of SQA processes across the organizations
• Experience in Computer Systems Validation (CSV) of computerized laboratory instrument systems (HPLC, Mass Spectrometers etc) in a regulated R&D and machine critical quality control lab environments
• Experience in testing of client server, Services Oriented Architecture, Web based, Mainframe based and three tier architectures across various test environment and on Documentum Webtop interfaces
• Involved in providing e-Learning Solutions using Need Analysis Database
• Experience in definition of the testing strategy for large scale programs and ensuring bidirectional requirements traceability throughout the system development lifecycle
• Instrumental in Integration of FDA, CFR Part 11, 210, 211 of Title 21 (21 CFR Part 211), RCI regulatory requirements into system design and associated validation deliverables
• Expertise in overseeing the development of test plans, test scenarios, test cases, execution of test cases and documentation of test results ensuring in meeting the industry defined quality standards
• Involved in providing e-Learning Solutions using Need Analysis Database

Professional Experience:

Confidential,NJ Oct ‘10- Present
Senior QA Consultant
The Global Market Access (GMAx) business processes currently rely on the manual generation and cross referencing of multiple reports, from disparate data sources, increasing the effort needed to conduct appropriate analysis and limiting efficiency. Consolidated data and the ability to generate single sourced graphical, standard and ad-hoc reports will simplify the business processes. A technical solution to provide these capabilities, while maintaining flexibility and agility is needed to the key business teams

Responsibilities / Achievements: Technical/Functional:

• Instrumental in developing, documenting and maintaining complex data TEST models for the project. Instrumental in process definition, training and implementation for RUP, AGILE SCRUM methodology across various organizations- defined and implemented the product, sprint and release backlogs for all scrum teams.
• Authored and maintained the Master Level QA Test Plan to ensure the plan is up-to-date with the latest changes made to the software for MPAP (Merck Price Approval Process).
• Elicited & documented the testing requirements & articulated them to the development team formally.
• Facilitated the Computer System Test Risk Assessment to identify governing regulations and validation deliverables during the development of the application.
• Interacted with the project development and release group in establishing the major milestone and target dates.
• Developed and maintained Project Charter (PC) in order to track and monitor the project performance and report the key items to all project stakeholders.
• Coordinated with the project management and development architects in identifying the high-risk performance areas for the application. Conducted Project Risk Categorization severity analysis based on which, the project was subjected to Risk Review Board (RRB) Involved in CSV based Risk Assessment.
• Responsible for Test planning, Test scheduling and Tracking. Identified the test deliverables. Gathered the testing scope, scope of the business transactions and performance test data, identified the execution environment.
• Setup the complete test lab and test environment, monitored the installation, configuration and setup of the application, Charm (defect) database, configuration databases, security features, server access rights to relevant stakeholders, Test environment (Hardware and Software) in compliance with FDA requirements.
• Acted as the primary liaison between the client and project stakeholders.
• Assisted DW (Data Warehouse) analysts in analyzing existing reports & identifying iteration metrics.
• Led preparation efforts for testing of data warehouse requirements document.
• Assisted data analyst in data mapping tasks and CRTs.
• Analyzed existing COGNOS reports and led the identification and documentation of business metrics.
• Determined systems of record with the assistance of appropriate source system experts.
• Helped the development team, identify sources of data for the data warehouse and Pega systems.
• Oversaw testing of data acquisition processes and their implementation into production.
• Act as consultant to the ETL and front-end programmers. Helped the data modeling team in preparing the data models. Reviewed the data models to ascertain that requirements are met.
• Defined, trained and implemented new processes across the organization.
• Developed POC (Proof Of Concept) for the business requirements and presented to senior management for MOSS 2010. Participated in Defect Management and resolution process.
• Interfaced and assisted the Business Users in defining the new process and identifying training needs. Well versed in requirements gathering on MS Sharepoint Services.

Environment: Oracle v9.6.1, SQL Queries, RMS v2.0.5 Websphere v5.1.1.6, SunOne 6.0 & Siteminder 5, Webmethods, COGNOS REPORT 1.1.601 MR3 w/ Websphere, eCabinet, HPQC, SAP, QTP, Documentum Webtop

Confidential, Princeton Oct ’08- Oct ‘10
Senior QA Lead, Government Pricing, Contract Management and Chargebacks
Bristol-Myers Squibb (BMS) has undertaken a highly successful project initiative to design and implement a new Government Pricing System (GPS) solution. GPS is used primarily to support compliance and administration in various government pricing programs. The new GPS solution based on package software from Model N, with enhancements and customizations as needed, to meet the requirements of BMS. The GPS solution was utilized primarily by the Government and Public Program Operations (GPPO) group within the U.S. Pharmaceuticals division of BMS, located in Princeton, New Jersey.
Responsibilities / Achievements: Technical/Functional:

• Executed and maintained SQL queries for the government pricing restatements
• Authored and maintained the Master Level Project Plan to ensure the plan is up-to-date with the latest changes made to the software
• Executed COGNOS reports to validate the performance, stability and responst time of the application
• Reviewed the pre and post executed test scripts
• Participated in Defect Management and resolution process
• Provided test execution training to Test team
• Responsible for system test execution and integration and test execution oversight
• Interfaced and assisted the Business Users in defining the new process and identifying training needs
• Implemented SOP 302 across the project successfully and also conducted ROI analysis for this implementation
• Well versed in integration of enterprise applications including SAP, PeopleSoft, Oracle, and Sales force

Environment: Oracle v9.6.1, SQL Queries, RMS v2.0.5 Websphere v5.1.1.6, SunOne 6.0 & Siteminder 5, Webmethods, COGNOS REPORT 1.1.601 MR3 w/ Websphere, eCabinet, HPQC, SAP, QTP, Documentum Webtop

Confidential, DE Jan ‘08- Oct ‘08
Senior QA Lead, Study Information System
The Commercial Architecture provided the foundation for managing information across the Commercial Enterprise. The ODS was geared towards capturing the animal study data at Species/Strain level in Drug Safety and Drug toxicology domain. The application was highly system validated and FDA compliant.
Responsibilities / Achievements: Technical/Functional:

• Instrumental in the evaluation, training and implementation of HPQC
• Maintained MS Project for the Project Schedule of the Requirements, Design, Build, Verification and Validation phases of the project. Also used MS Visio to develop the performance environment diagrams
• Conducted the review and sign off of the project plan, project quality plan
• Facilitated the Computer System Test Risk Assessment to identify governing regulations and validation deliverables during the development of the application
• Interacted with the project development and release group in establishing the major milestone and target dates
• Developed and maintained Project Charter (PC) in order to track and monitor the project performance and report the key items to all project stakeholders
• Coordinated with the project management and development architects in identifying the high-risk performance areas for the application. Conducted Project Risk Categorization severity analysis based on which, the project was subjected to Risk Review Board (RRB) Involved in CSV based Risk Assessment
• Responsible for Test planning, Test scheduling and Tracking. Identified the test deliverables. Gathered the testing scope, scope of the business transactions and performance test data, identified the execution environment
• Setup the complete test lab and test environment, monitored the installation, configuration and setup of the application, Charm (defect) database, configuration databases, security features, server access rights to relevant stakeholders, Test environment (Hardware and Software) in compliance with FDA requirements
• Played a key role as an active interface between the functional and the performance testing teams in resolving test data discrepancies, environment setup issues.

Environment: Oracle 10g, JAVA, Test Director, Win runner, Rational Clearcase, MS Project, MS Visio, Full Circle (In-house), Rational Test Real Time, Documentum Webtop, Mercury Quality Center, PVCS, ClearQuest

Confidential, Malvern, PA Sep ’06- Jan ‘08
Functional Test Lead, TrueD Vision
The project deals with the Pharma Research Data collected from different researches and tests conducted on the subjects. Data Warehouse collects full life cycle data for Siemens products right from the new product introduction through its manufacturing, testing, shipping, and success and failure analysis. The project piloted the AGILE methodology
Responsibilities / Achievements: Technical/Functional:

• Instrumental in implementation of AGILE SCRUM methodology in the project
• Led AGILE training team and provided trainings to project SCRUM teams
• Developed and maintained the Training material for AGILE methodology
• Priotitised the PRODUCT BACKLOG requirements, developed and maintained SPRINT BACKLOG at release level
• Instrumental in acahiveing SEI- CMMI V1.2 assessment for AGILE methodology, assessment being first of its kind in the history of SEI
• Derived, analysed and presented EFFORT BREAKDOWN metrices to the senior management on a monthly basis through SPRINT closure meetings
• Identified the key business/decision points of the application for performance analysis and benchmarking
• Played as a key interface between the end users, Test users,offshore team and Developers
• Designed the user acceptance end to end transaction test cases for the PE Controls application
• Created of mapping documents for the Use cases, Business rules of the middleware, data validation. Established traceability between requirements to design to code to test cases. TMS Master Tool was used to manage the Unit Test like Unit Test Data and reports. Identified test cases for the developed features for every increment. The test cases were generated using NUnit test source code. Test Management System, TMS Test Info Visual Studio add-in was used to fill in the required information for each test case. This information was then used to parse the data into TMS database
• Performance test cases were designed to locate and isolate the key functional modules for automation
• Recording the interactions of the application and the server with respect to response time and data handling. More emphasis was laid on usability testing.
• Regression testing against the test environment was performed, creation of data pools as test data for the transactions
• Conducted defect sampling and Root Cause Analysis (RCA) and Prepared/Presented Defect Analysis Reports. Automated the functional test scenarios using Silk test as part of tool implementation study.
• Presented better defect tracking/reporting procedures, test plan and design document templates and processes
• Successfully delivered the key deliverables (defect sampling report/data, root-cause analysis document, and review feedback of the use case documents) of this performance analysis operation to the project management group.

Environment: Oracle 9i, Documentum, Test Director, Winrunner, Rational Clearcase, MS Project, MS Visio, Full Circle (In-house), Rational Test Real Time, MS Office suite, Load Runner, Mercury Quality Center

Confidential,Mar ‘06- Sep ‘06
Test Lead, PE Controls
The scope of Platform Engineering Controls was to develop Graphical User Interface (GUI) Controls for platform engineering, for the planned GUI Controls, features were investigated and identified based on the GUI Feature list.
Responsibilities / Achievements: Technical/Functional:

• Drafted the test process/methodology with high impetus on risk assessment and management. Evolved mitigation and contingency plans to handle risks, resource management and allocation
• Test planning, Test scheduling and Tracking. Presented Project Management Plan with impetus on adaptive techniques
• Identified testing scope and deliverables for each phase of the iterative/spiral/RAD model
• Design analyzing and documenting the functional and non-functional requirements, mapping the use cases to the business scenarios
• As a key interface between Product Development and Architecture team in supplementing with new design changes and ideas and making them available to all the MIS teams
• Designed, documented and implemented transaction test cases, security test cases and work allocation of the functional modules to the QA personnel
• Built a user-friendly yet a vigilant test process starting from the migration to analysis, design and development of Test Plan, Test case design documents, Defect analysis/tracking, Defect trend charts
• Was in charge of build releases to the QA and Production server and build deployments on deployment servers. Was responsible to obtain formal sign- off before build release to end- user
• Handled the site portal for Site Registration, Customer Authentication, Creating/Managing new test sites, troubleshooting and guiding the team in locating the critical high security areas
• Proactively identified test process improvements, test effort standardization and re-usability across the project
• Evolved the processes of Creating, Testing, Validating and loading data into Oracle8i DB
• PL/SQL’s script manager was used in writing the SQL queries and validating the query results with the websites results
• Test Track was used to log the defects. Evolved a bug reporting and escalation process
• Functionalities were automated using Silk test, based on the stability and criticality of the modules in the product
• Test metrics and deliverables were documented and presented to business and IT group
• Instrumental is achievement of high success rate in the product release VDR2.0B with a high level of customer satisfaction

Environment: Oracle 9i, Documentum, Test Director, Winrunner, Rational Clearcase, MS Project, MS Visio, Full Circle (In-house), Rational Test Real Time, MS Office suite, Load Runner.

Education: Bachelors in Electrical &Electronics Engineering