SUMMARY

• Four years of diverse experience in Validation, and Quality Assurance.
• Good knowledge of Software Development Life Cycle, and Validation Practices.
• Hold Strong Analytical, Design, Development, Validation, Documentation, Maintenance, Issue Resolution and Change Control procedures expertise.
• Detail oriented and strong SQL querying skills.
• Numerous years of experience in Software Quality Assurance and Quality Control .
• Thorough understanding of the software development lifecycle and validation lifecycle with the emphases on the manual and automatic testing.
• Expertise in using automated testing tools such as Win Runner, QTP (Quick Test Professional), LoadRunner and Quality Center.
• Creating user requirements document by interacting with the end users and developers.
• Understanding of Claims Adjudication.
• Knowledge and working experience in GLP, GMP and GCP regulations.
• Competent in quality system and standard 21 CFR (part 11, 20, 50, 58, 210, 211, 820) gap analysis and remediation plans.
• Expertise in developing validation protocols, execution tests and construction of summary reports IQ/OQ/PQ’s.
• Designed and developed Validation Master Plan (VMP).
• Used PL/SQL procedures to validate or test the Database.
• Expertise in technical writing and report generation.
• Gained experience in Load, Stress, Performance, Regression, System/end to end testing.
• Proven ability to work efficiently in both individual and team based environments.
• Excellent communication and organizing skills with the ability to grasp and learn quickly.
• Proficient in dealing with Standard Operating Procedures (SOPs), Test Plan, Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS).
• Expertise in troubleshooting complex problems.

TECHNICAL SKILLS

Operating System: Windows2000/2003/xp/vista/7/NT MS - DOS, Mac OS

Language: C, SQL, Visual basic, VB Scripting

RDMS: MS Access, Oracle 8i/9i/10g, SQL Server 2000

Tools: MS Visio, MS project, MS Office (Word, PowerPoint, Excel, Access, Mac OS, Documentum, WinRunner/Load Runner/Quick Test Pro Systems (QTP)

Bug Tracking and Reporting: Mercury Test Director, PVCS Tracker, Rational Requisite Pro, Clear Quest

Regulations: FDA quality system regulations 21 CFR (part 11, 50, 58, 210, 211), GxPs, IQ/OQ/PQ, LIMS, AERS, Audit Trails

PROFESSIONAL EXPERIENCE

Confidential, Knoxville, TN

Quality Assurance

Responsibilities:

• Worked with Agile Scrum team and involved in daily scrumactivities.
• Responsible for creating all task related to testing during the sprint planning.
• Responsible for writing Test Case and Test Script for every user story.
• Prepared Test Plan and Test Cases in requirement meeting, analysis and design phase.
• Tested Web Services using SoapUI and SOA.
• Reported Defects to developer and generated Test Reports.
• Created Screen Shots for using Selenium JUnit for all Applications in project.
• Implemented the Data Driven into SoapUI and tested various functions in Web Services.
• Performed Integration Testing and implemented test cases for GUI Functionality, Positive and Negative Testing.
• Involved in testing SOAP service and used SoapUI/SoapUI Pro client to test those services.
• Ran SQL Queries to retrieve from and update databases using MySQL.
• Creating automation framework using Selenium (Keyword Driven Frame work).
• Automated Web Servicing testing with SoapUI Pro.
• Initiated new processes for improving the quality through out the QA team.
• Responsiblefor creating all sort of test documentation for scrum team.

Confidential, Mountain View, CA

QA Engineer

Responsibilities:

• Tested Web Services using SoapUI, XML and JSON.
• Worked with Users, Business Analyst where I gathered business and technical requirements and specifications.
• Developed Test Plan and Test Strategy.
• Used automated QTP tools for Regressions and Functional testing.
• Used Quality Center to report all defects, defect status and closure information. Ensured that data were correctly reported in it when defects were resolved or closed.
• Documented Test Data and Test Status Report using Microsoft Excel and Word 2003.
• Used Rational Requisite Pro to arrange and to maintain to keep tracking the frequently changing requirements.
• Assigned the fail test cases to the particular developer and communicated with the developer to resolve them.
• Participated in Weekly Status Meeting with the development and management team to discuss bugs and other issues.

Confidential, Cambridge, MA

Validation Analyst/Technical Writer

Responsibilities:

• Gathered, reviewed and analyzed User Requirements and Functional Requirements.
• Validated LIMS applications and customizations, including database tables and reports, labeling and barcode systems, and interfacing with laboratory instruments under CMM environment.
• Developed UAT/PQ scripts and conducted training and coordinated UAT testing.
• Involved in all stages of equipment validation life cycle.
• Prepared Validation Master Plan (VMP) and other validation deliverables like IQ’s, OQ’s, and PQ’s.
• Ensured project activities are in compliance with FDA and internal standards.
• Developed Standard Operating Procedures (SOPs), Training/User manuals and ensured compliance with 21 CFR Parts 210, 211.
• Maintained Requirements Traceability Matrix (RTM) to track requirements.
• Used QTP for Regression and Functional testing.
• Performed GAP Analysis and prepared Remediation plans.
• Made Deviation and Failure investigations for the deviations found in the system.
• Conducted reporting and tracking of defects using Quality Center.
• Generated a Validation Summary Report (VSR) to summarize the overall validation effort.