SUMMARY

• More than 8 years of experience in software Validation, Technical Documentation, Quality Assurance as a Validation Engineer and Quality Analyst.
• In depth knowledge of SDLC - Software Development Life Cycle and various methodology such as Agile, Waterfall model, V model.
• Well versed wif all stages of validation and testing of application
• Thorough knowledge of 508 - compliance & Regulation.
• Strong experience wif development and reviewing of Validation Deliverable such as Validation Master Plan, Requirement Traceability Matrix, Validation Protocols, Validation Summary Report, Remediation Plan, Gap Analysis, Training Plans.
• Expertise in creation and execution of ATE & End-to-End system test scenario.
• Strong hands on database query creation and debugging of SQL Script.
• Hands on experience of reviewing and modifying User Requirement Specification (URS) and Functional Requirement Specification (FRS).
• Proficient in creating and maintaining Validation Matrix along wif Qualification Documents, Validation Status Report.
• Hands on experience reviewing, developing and executing Test Plans, Test Cases, Test Scripts, Test Scenario, Work flow Diagrams
• Strong experience wif Automation tool such as HP Quick Test Pro.
• Expertise in preparation of Backup and Disaster Recovery plan.
• Hands on experience wif Application Life Cycle Management (ALM), HP Quality Center.
• Thorough knowledge of Corrective and Preventive Action reporting, handling and closing using software system like track wise.
• Specialization in Defect tracking from Test protocol using ALM - defect module.
• Good experience of Database Testing using SQL Queries.
• Thorough knowledge of various phases of Validation Life Cycle.
• Specialization in System testing, Integration Testing, Performance testing and Regression Testing.
• Capable to work independent as well as team player.
• Excellent interpersonal communication and writing skill.

TECHNICAL SKILLS

Automation Test Tools: HP Quick Testing Pro 9.2/ 11, Load Runner 7.5, Win Runner 7.6

Test Management Tools: HP Quality Center 8.2/9.2, Mercury Test Director 7.2, ALM

Graphical: User Interface MS window, Visual Basic

Defect Tracking tool: Bugzilla, ALM 11.0

Web Technology: HTML, .NET

508 too: l Dragon, Jaws, Magic

Language: SQL, VB script

Change: Management Track wise

PROFESSIONAL EXPERIENCE

Confidential, Gwynn oak, MD

Sr. QA Analyst

Responsibilities:

• Detail gap analysis of requirement and verification of scoping for case request.
• Creation of functional test case, End-to-End test case, smoke test on development build based on specification as part of Agile Team.
• Execution of Test protocols and creation of variation defect using HP quality center.
• Developed and maintained Requirement Traceability Matrix to verify requirement are being met during Test Execution Phase.
• Performed 508 compliance verification using MAGIC, JAWS, DRAGON tool.
• Review of Test documentation and provided comments based on SOP.
• Smoke test execution and reporting build verification status.
• Database verification by creating SQL query in IBM DB2.
• Test data maintenance and deletion as per request from Validation team.
• Assistance to development team for re-verification of scenario in pre-development environment.
• Extensively performed backend database testing using SQL Queries.
• System Test scenario verification and execution on validation build.
• Verified requirements, mapped wif existing test protocols, and ensured requirement traceability matrix.
• Execution of Automation script for filling test data as well NDDSS data cleanup using HP QTP.
• Maintenance of automation script for case request.
• Execution of function and system test scenario in test lab for each sprint.
• Creation of Validation Plan and Validation report for teh ongoing test activities.
• Performed Data migration and post migration verification activity for various releases.
• Test Data creation and maintained in mainframe and EDCS application.
• Report creation for sync in Test Lab and Test Plan for existing Test cases.
• Provided support on System Test for End-to-End scenario, Flow charts and extensive Documentation and Reporting.
• Attended Status meeting and provided project status every week

Environment: HP ALM 11.0, IBM DB2, JAWS, MAGIC, DRAGON, Rational Requisite Pro, HP QTP 11.0, Mainframe system, EDCS, FECS user interface tool, DMA

Confidential, Mason, Ohio

Validation Analyst / QA Analyst

Responsibilities

• Worked closely wif Technical team and Business Analyst for review and update User Requirement Specification and Functional Requirement Specification.
• Reviewed Validation Deliverables throughout teh entire Validation Lifecycle of teh Adverse Event Reporting System (AERS).
• Developed Validation deliverable such as Requirements Specification, CSV Risk Assessment, Validation Plan, Qualification Documents, Requirement Traceability Matrix, Test plan, Test Summary reports.
• Prepared Standard Operating Procedure (SOP’s) for Deviation Handling, Revalidation, Change Control, and System Administration.
• Assisted for developing Validation Master Plan for Oracle Adverse Event Reporting System as per teh compliance guideline.
• Strictly followed SOPs and industry best practice for teh Validation Life Cycle Phase.
• Created all Testing Deliverable like Test Plan, Test Cases, Requirement Traceability Matrix and Testing Strategy.
• Reviewed and Prepared Qualification Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Executed Installation Qualification, Operational Qualification and Performance Qualification during Validation Life Cycle.
• Verified Functional requirements for Graphical User Interface of teh AERS Study module using teh HP Quick Test Professional tool.
• Coordinated teh validation activities to reduce protocol execution time and to meet project milestones.
• Assisted in planning, implementing as well as documenting user acceptance testing during teh validation life cycle.
• Thoroughly used HP Quality Center to track, analyze and create defect report for Test script.
• Performed back end testing for teh Oracle database by pulling SQL Script.
• Created Change request using Track wise software, Assisted in Back up and performance Monitoring and structured Change control Procedure for validated AERS.
• Developed Validation Summary Report and Overall Test Summary Report and forwarded to teh Quality Assurance Team for further review.
• Provided Weekly Status Report for teh project as per teh management requirements.

Environment:AERS Unix, HP Quality Center, Oracle 8.0i, Visual Basic 6, HP Quick Test Pro10.0, Window 2000, ASP, HTML

Confidential, California

Validation Engineer / QA Tester

Responsibilities:

• Participated in preparing SOPs for teh Administration and Security for teh validation of LIMS.
• Developed, analyzed, reviewed and summarized Validation Documentation, Test method Data, Specification Changes.
• Developed Validation Master Plan flow chart, which synthesized activity and shorten project completion time.
• Developed Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Plan, Validation Registry, Test Execution Report.
• Analyzed User Requirement Specification and wrote Test Cases and Test Script for Operational Qualification and Performance Qualification for LIMS.
• Executed Graphical user Interface Testing to verify Functional requirement and Regression testing using teh HP Quick Test Pro and prepared execution test report.
• Actively executed test script for Functional, Regression and Integration manually as well as Automation
• Created Test Execution Report as per teh compliance requirement.
• Executed Performance Qualification in teh Production Environment and verified User Requirements.
• Developed and maintained Requirement Traceability Matrix to reflect any changes in qualification and requirement specification documents.
• Worked on Deviation investigations, Quality System development, Documentation Control and Equipment Qualification as per teh compliance requirement.
• Worked on Change Request to implement changes in teh validated system as per teh Change Management Process to determine impact of any changes on Validated Laboratory Information Management System.
• Traced, analyzed defect and generated bug report using HP Quality Center.
• Extensively performed backend database testing using SQL Queries.
• Created and maintained Validation Registry and Validation Summary Report.
• Thoroughly used MS word and MS Excel and PowerPoint for teh presentation, Graphs, Flow charts and extensive Documentation and Reporting.
• Attended Status meeting and provided project status every week.

Environment: Window 2000, SQL-server, LIMS, ASP, Visual Basic, HP Quality Center 9.2, HP Quick Test Pro9.2

Confidential

Validation Engineer / QA Tester

Responsibilities:

• Attended Status meeting and provided project status every week.
• Facilitated Failure Mode and Effects Analysis for EDMS to identify associated risk to teh system and provided Remediation strategy plan.
• Performed Gap analysis to rectify teh gap of teh current system and implemented Change Control Process as per teh Change Control Management System.
• Reviewed User requirement specification and Functional Requirement Specification for EDMS by interacting wif Business and Technical team.
• Created Standard Operating Procedures for Backup, Periodic Review and Change Control Management.
• Reviewed Computer System Validation Protocol such as Validation Master Plan, Validation Summary Report, Qualification Documents, Requirement Traceability Matrix).
• Developed and enhanced Validation Master Plan and Validation Summary Report as per teh FDA compliance guideline.
• Responsible for writing Test Case and Test Scripts for teh Installation Qualification (IQ) and Operational Qualification (OQ) as per teh FDA Guideline.
• Created Test Plans, Test Scenarios and Detailed Test Cases based on teh Use case documents, Business requirements and Functional Specification.
• Performed Functional Testing, Performance Testing, Integration Testing, System Testing according SOP’s and assured validation in compliance wif cGxP’s.
• Developed and maintained Requirement Traceability Matrix to verify requirement are being met during Test Execution Phase.
• Assisted in technical writing of teh User Manuals for teh EDMS application as per compliance requirement.
• Executed data-driven testing for teh E-signature verification using HP Quick Test Pro by pulling different values from external file (Excel).
• Executed test cases for System testing and tracked, analyzed bug and prepared bug report in Test Director 7.0.
• Extensively used SQL queries to perform Back-end database testing using SQL Management Studio 2008.
• Assessed 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures to access data security issues like authorization and login.
• Developed Business Continuity plan and reviewed Disaster Recovery plan.
• Assisted in development of Periodic Review strategy plan to verify teh system is still in validated state as per compliance requirement.
• Worked for planning, implementation and documenting User Acceptance Test cases and Test Scenario.
• Drafted Requirement Traceability Matrix to trace back Requirement wif test cases.
• Collected list of all validation deliverable and created Validation Registry.
• Assisted in development of Validation Summary Report and concluded all deviation as per FDA guideline.
• Discussed project status in weekly Project meeting and process review meeting and reported Test execution results.

Environment:Windows 2000, EDMS, HP Quality Center 8.2, MS office, Bugzilla, Visual Basic, .NET, SQL