SUMMARY

• QA/Validation Analyst with over 16 years of diverse experience in Quality Assurance, Validation, Software Testing, Business Value and Analysis.
• 5 plus years of experience as a software developer using C, Java, VB etc…
• Result Oriented Professional Engineer with knowledge of Business Processes, Workflow, Quality Assurance & Validation processes.
• Excellent Management skills in delivering quality products to meet regulatory & business requirements.
• Experience in validation of Document Management System, Clinical Trial Management System(CTMS), Clinical Data Management System(CDMS), Electronic Data Capture (EDC), Adverse Events System, Clinical /R&D Applications both COTS and in house products.
• Expertise in SDLC models like Waterfall, V - Methodology, Agile, iterative, SCRUM and Puma.
• Conversant in all aspects of testing viz. Smoke, Unit, Black Box, Gray box, System, Integration, Functional, Boundary, Database, GUI, Load, Back-end, Regression and UAT Testing.
• Authored and actively participated in Test Design, Test Scenario, Test Plans, Test Cases, Test Scripts, Test Tracking and Summary Reports.
• Active participation in Systems Criticality Assessment (SCA) and Functional Risk Assessment (FRA) in strict compliance with 21 CFR and GXP impact.
• Actively participated with team in delivering timely communications with regulatory agencies like FDA, EMEA and PMDA.
• Represent Systems Validation/Testing and transition in cross-functional teams on projects with major and critical GXP impact.
• Participated and authored Systems Design Specification (DS), Functional Requirement Specification (FRS) and User Requirement Specification (URS) documents, Technical Impact Analysis for Change Controls.
• Competent in testing Client/Server, Web Based & Stand-Alone java/.net applications.
• Experience in Manual Testing & Automated Testing tools like QTP, Selenium, Neoload, JMeter, QA Wizard Pro, Win Runner and Load Runner for applications developed in VB.Net, VBA, ASP, Java, C#.
• Proficient in using various Bug Tracking tools like BMC Remedy, Quality Center, Rational Clear Quest, Bugzilla, Team Track, Test Track, HP ALM.
• Expertise in IQ/OQ and PQ deliverables, participated in drafting & finalizing Requirement Traceability Matrix (RTM), Validation Plan, Validation Summary Report (VSR), Release Plan,Release Summary,Test Plan,Test Summary, Support Plan and Authorization for Use (AFU).
• Worked on opening & managing Change Control/ Release Management.

TECHNICAL SKILLS

Testing Tools: Load Runner 7.6/8,Quick Test Pro (QTP) 8.2/ 9/ 9.2, Win Runner 7.0, QA Wizard Pro 2012, Selenium 2.0, Neo Load 5.0, Jmeter 2.12,ALM 12.

OS: Windows 2003/2007/8,Citrix Metaframe 9/11,Unix (HP & RedHat 7.x)

Middleware: Tomcat 6.x, Web 2.0, XML, SOA, MVC, J2EE, Web Services.

Defect Management: BMC Remedy ITSM 8.x, Quality Center 8.2/9/10, Test Director8.0, Rational Clear Quest, PVCS Bug Tracker, Bugzilla, Team Track 6.5, Test Track2011, MS Visual Studio 2010,HP ALM 11.

Languages: BASIC, C, C++, PL/SQL, Java, VB, VBA, Unix Shell Scripting, XML, VB Scripting, Java Scripting, C#,.Net.

RDBMS: MS SQL Server 2008, ORACLE, TOAD, MS SQL, MS Access 2003/2008.

Utility Applications: MS Office, Crystal Reports, Visio, PC Anywhere, Query Analyzer, Adobe 7.0, Power Shell, Seapine Surround.

Collaboration Tools: eRoom, Sharepoint portal, Documentum.

Clinical Application: Inform EDC, Livelink, JReview, IReview, Imedidata/Rave, SAS, Central Coding, Central Designer, Central Lab,ARISg,Biology and Chemistry Enotebook application.

Documentation: Business Requirements Document, Functional Requirements Document/ Functional Requirements Specifications/ Functional Specifications Document/S/w Requirements Specification, Non-functional Requirements, Use Cases, Data Elements, Test scenarios, Test Cases, Requirements Traceability Matrix, Business Process Maps/Flows- AS-IS (current) and TO-BE (future), Defect logging, Change and release summary.

Compliance: 21 CFR 11, 210, 211, 820, ISO 9001, Six Sigma, LEAN, GXP, ICH, cGMP.

PROFESSIONAL EXPERIENCE

Confidential

QA Team Lead

Responsibilities:

• Participated in meetings between Application Owner,Business Owner,Subject Matter Expert (SME) Development and Validation Team for coming up with a process to manage the Change Control for Validated and Non Validated templates and plugins for eWorkbook.
• Created a Gap Analysis for functionality that was under impact to create the test cases required for the change request.
• Authored Test Plan, SIP (Solution Implementation Plan)and SIS (Solution Implementation Summary).
• Participated in reviewing Project Plan, Technical Risk Assessment Document, Change Request, Architectural Design Documents, Validation Plan.
• Opened and managed the life cycle of the change control in form of SIP (Solution Implementation Plan)and SIS (Solution Implementation Summary)in Change management application Vitalize.
• Tracked, updated and maintained Traceability Matrix (RTM) based on functional requirement updates.
• Participated in System and UAT testing and communicated the routine status of the testing internally within BMS and externally within the client and to the team and Application Owner.
• Worked on the test cases creation, execution and maintenance of the whole testing life cycle in HPALM .
• Logged defects internally in HP ALM and externally within JIRA for the vendor.
• Participated in regular meetings with Application Owners, Validation and Development Team.

Environment: IDBS eWorkbook9.4, CambridgeSoft eNotebook2014, .NET,HP ALM 11, Vitalize (Service Now), Share Point,JIRA, MyQUMAS DOCIT 4.1,MS Project,Ms Visio.

Confidential

Team Lead

Responsibilities:

• Coordinated and managed Regulated Change Control between Business Owner, Information Technology, Validation and Quality Units based on PUMA methodology.
• Participated in authoring and reviewing technical Impact Assessment, User Impact Analysis and Service Impact Assessment.
• Reviewed the Impact assessment document with project team that was created based on Release Notes and build reports.
• Opened and managed the life cycle of the change control as change coordinator using BMC Remedy ITSM change management module.
• Tracked, updated and maintained Traceability Matrix (RTM) based on functional requirement updates.
• Performed Edit Check and static and dynamic (dry run) IQ, OQ and PQ script reviews.
• Reviewed Installation Plan, IQI (installation incidents), IQ Forms and Installation Summary.
• Executed EDC Signature Trial OQ and PQ Regression scripts.
• Created Change Summary document to address Impact Assessment, Service Impact Assessment, Risk Assessment, Change Plan, Test plan, Test Cases, Backout Plan etc.
• Participated in creating Release Summary document, by gathering all change implementation details, Test results, IQs, SIT and UAT execution results.
• Logged and assigned defects in MS Visual Studio 2010.
• Updated project control book (PCB) for release management for reported Anomaly and Incidents that needs to be addressed in next release.
• Maintained test tracking spreadsheet with the system test & user acceptance test progress.
• Managed change control life cycle including change closure and release summary report.

Environment: MS SQL Server 2008, MS Visual Studio 2010, XML Web services, CDISC ODM, Share Point, MS IIS 7.0,.NET Frame Work 3.5 SP1,BMC Remedy IT Service Management 8.0, MS Office .