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QA Lead

Ashburn, VA
March 06, 2018

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SOWMIYA MURUGESAN 732-***-**** Ashburn, VA

Professional Summary

** ***** ** ********** ** Quality Assurance in various capacities in the role of Validation Lead, Sr. Validation Engineer, QA Coordinator/ Engineer

Validation Lead in Pharmaceutical/Medical Devices Industry; involved in testing of eCOA (Clinical outcome assessments), ePRO (Patient Reported outcome) and EDC (Electronic Data Capture) systems

Solid understanding of 21 CFR Part 11, GCP guidelines and regulations

Extensive knowledge in configuring and usage of Mobile (SITEPad, LogPad, SITEpro, DIARYpro) and Medical devices (Master Scope, ECG); data transfer, analysis and data correction/coordination of clinical data from the devices

Expertise in Preparing effort estimation, Requirement Analysis, Gap Analysis, Business Impact analysis, High level design, Schedule and task tracking, Problem analysis, Validation Protocol/Plan, Test Strategy, Test cases (IQ, OQ, PQ), Test Reports, Requirements Traceability document, Summary Report, SOPs and Training manuals, Reviews, Business support, Status reporting and Knowledge Management

Experience in Manual, Automated Functional Testing (using Win Runner and Quick Test Professional), Automated Load Test Tool and monitoring tool (Load Runner and Sitescope)

Win Runner, QTP Test Automation includes Test Automation script development, Test Automation framework development, Functionality & Regression Testing

Proven success in scripting different applications (Web, Web service and ERP) with Automated Test Tools and perform Load, Stress, Endurance and Capacity testing and server utilization analysis

Have extensively used Test Director/Quality Center for managing the Test Requirements, Test Plan, Test execution and Defect Tracking

Experience working in SDLC and Agile Methodology; managing offshore team

Technical Skills

Test Analysis

Functional Requirement Gathering & Analysis, Analyzing Business Rules, Test Flows, Test Planning, Test Case creation (IQ, OQ, PQ), Test Reports, Traceability document, Defect Tracking & closure, System Change Request, Impact Analysis

Test Management

Test Director, Quality Center

Mercury Interactive

QuickTestPro, Quality Center, Test Director, LoadRunner, WinRunner

Bug Reporting

JIRA, TestDirector, Quality Center, Bugzilla

Medical Device

SITEPad, LogPad, SITEpro, DIARYpro, ECG, WAMPC, Master Scope

Reporting Tools

Cognos, Business Objects

Analytics Tool


Webservice testing

SOAPUI, Postman

Monitoring Tools

Sitescope, Perfmon


Oracle and MS Access

Web Development



PeopleSoft HR 8.8 (eRecruit, ePerformance and eCompensation), Finance 8.8 (Accounts Payable, Asset Management, General Ledger, Procurement, eExpense, Purchasing and eProcurement)

Current Experience

Client: ERT Nov 2010 to Aug 2017

Project: EXPERT/ePRO

Role: Validation Lead


Responsible for planning, monitoring, and control of the testing activities for multiple applications

Create/maintain Test Strategies and Test Plans according to Test Objectives and Organizational Test policies

Lead, guide and monitor the analysis, design, implementation and execution of the test cases, test procedures and test suites based upon requirements

Create/maintain various testing artifacts and testing reports during the lifecycle of the project

Hold and facilitate test plan/case reviews with cross-functional team members

Oversee Software Verification Testing performed by assigned team members, to ensure timelines are maintained and quality documentation are developed

Conduct functional, data accuracy and security/role-based testing of Web-based and mobile applications

Train/manage and work closely with onsite and overseas SQE teams, monitor testing efforts and ensure defects are addressed prior to release

Validation of Site Performance Analytics using Tableau; Validation of Extraction, Audit, Session, Reminder, missed visit reports using Cognos

Automate the test scripts for GUI, Functional, Data-Driven and Regression testing using QTP

Involve in Requirements Gathering, Requirement Analysis, Scenario Identification, Test Planning of Performance testing. Complete Performance Qualification (PQ) by creating Load test scenarios, executing the same and analyze the results using LoadRunner Analysis module and publish reports

Conduct and/or actively participate in meetings related to the multiple project/s, with clients and/or other contractors

Provide support / consultation for a successful UAT.

Create and maintain Requirement Traceability Matrix (RTM) and ensure complete test coverage

Assist in the development/review of standard operating procedures related to the development, configuration, evaluation, implementation, and testing of systems

Advise and recommend organizational testing strategies, processes and methodologies

Share best practices, lessons learned and knowledge with the rest of the team

Previous Experience

Customer Name/Project Name





Celgene - PRiME System, Data Migration

Aug 2009

Oct 2010

Warren, NJ

Team Lead & Automation Test Specialist

Celgene - QTP 10 Tool Validation

Jun 2009

Jun 2009

Warren, NJ

Senior Validation Engineer

Celgene - USRMS, RAO

Aug 2008

May 2009

Warren, NJ

Validation Engineer

Capital One - ICORE, Knowledge Link, Capstone, Corporate Intranet Portal, PeopleSoft Hibernia Bank Integration – eProcurement and Re-platforming Exercise

Jan 2005

Jul 2008

Richmond, VA

Performance tester

Capital One - PeopleSoft HR and Finance Regression Suite

Oct 2003

Dec 2004

Chennai, India

Automation Test Engineer


Bachelor of Engineering

(Information Technology)

Bharathidasan university, Trichy, India

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