Test Cases Management

Areas of Expertise

SDLC Methodologies – Waterfall, V, Agile, SCRUM and PUMA

Validation

GXP impact, System criticality, Functional risk assessment etc.

Testing

QTP, HP ALM, Win Runner, Load Runner

Development -

C, VB, Java, C NET

Compliance

21 CFR, ICH, ISO, GXP, cGMP etc

Regulatory Agencies

FDA, EMEA, PMDA, CDISC etc.

Documentation

Test Design, Test Plan, Test Cases, Test Scripts, change and release Summary Reports.

Domain

Life science, Clinical, Finance, Insurance and Airline.

Sangeeta Verma

Cell: 609-***-**** Email: *************@*******.***

Career Profile

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, UTF,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,LIMS.

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

Bristol Myer’s Squibb, Lawrenceville,NJ Aug 2015 - Dec 2016 Bristol-Myers Squibb (BMS) is one of the leading global BioPharma companies focused on discovery, development and delivery of innovative and high quality medicines to patients all around the globe with serious diseases.

Project Title: CambridgeSoft ELN NoteBook 2014 and IDBS eWorkbook 9.4.1

Client: Bristol-Myers Squibb(BMS)

Role: Validation Lead

Description: E-Notebook is an electronic lab notebook that helps researchers and scientists to plan and record the experiments with enhanced productivity and accuracy .It also helps facilitates daily record-keeping and helps scientists in managing diverse types of data on electronic pages .

Biology and Chemistry scientist within the BMS R&D use these different eNotebook application and their plugin and integrations for managing,executing and planning their experiments, creating experiment templates, automating calculations, enabling tracking of chemical and biological samples and their properties for drug discovery etc .E-Notebook also provides them electronic signatures facility and a full audit trail with change tracking for compliance with 21 CFR Part 11.

IDBS eWorkbook 9.4.1 enables Biology scientists to write their assays and experiments on Electronic notebooks and draw inferences, instantiate experiments based on validated template frameworks, create and manage specimens in the Biobook experiment. eWorkbook also helps managing,processing and reporting of data and displaying it in views and charts.

CambridgeSoft ELN 2014 application is primarily used by chemists and Chemistry scientist to set up experiments and reactions, manage compounds/products, stoichiometry calculations, reaction preparations, create analytical methods etc. It also can create templates to clone frequent experiments and help scientists configure ELN to match their workflows and to supply and retrieve information from other Enterprise systems. It can also integrate with data analysis tools and introduce custom search strategies.

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,oracle.

Express Scripts (UBC), Blue Bell PA July 2014 – Feb2015

Express Scripts provides a range of pharmacy benefit management (PBM) services primarily in the US & Canada. The company offers healthcare management &administration services on behalf of its clients thus providing integrated and comprehensive clinical, safety, commercialization services.

Project Title: EDC (Electronic Data Capture) P2P Signature Trial.

Client: Novartis

Role: Team Lead.

Description: This Project enables a fully validated and qualified EDC application in Test and Production environment to add new Cancer Types and additional visits to a Novartis protocol. Application is based on Microsoft platform technology with XML services and CDISC ODM standard.

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 .

Hazel Tree, New York, NY May 2012 - Feb 2014

Hazel Tree offers comprehensive Treasury Management Solution enabling hedge funds and institutional investors to manage their increasingly complex environment through an interactive portal, across multiple prime brokers, counterparties and regulatory regimes thus enabling them to improve fund performance and reduce operating risk.

Project Title: Treasury Management Solutions

Client: Hazel Tree Fund Services

Role: Team Lead.

Description: This application brings real time data from multiple trading systems and market data sources into a single platform thus providing transparency across all counterparties in real time.

Responsibilities

Attended business Review meetings, worked as a Team Lead and Offshore Coordinator.

Performed database, SSRS Report, manual and automation testing of web applications on various web browsers.

Performed In depth testing of Treasury Management, Security Management, Margin Analytics, OTC Collateral Management, Portfolio Management, Compliance/Regulatory Filing, and Reconciliation modules.

Designed Validation Plans, Test Cases and Defect Reports and performed system validation, unit testing and user acceptance testing (UAT).

Created Defects and Executed Test Scripts & performed routine Test Lab Deploys.

Worked very closely with the Project Management office to finalize high level requirements and communicated status updates and risks to senior level.

Initiated and implemented change control.

Gathered, Maintained and Executed Change Requests in functionality and full lifecycle processes of internal projects.

Created user stories, translated requirements stories into task for each sprint/iteration and estimated development efforts for the task.

Facilitated Scrum meetings with the development and QA teams and planned iteration tasks.

Managed backlogs, logged and assigned new customer defects to developers and performed code review.

Authored training plans and user manuals.

Evaluated and performed Gap Analysis to identify management and technology operational gaps.

Participated in Systems Criticality Assessment (SCA) and Functional Risk Assessment(FRS) and authored Systems Design specification (SDS).

Worked on automating the testing efforts for these applications using Selenium.

Environment: MS SQL Server 2008, Seapine Surround, Test Track 2011, Power Shell, QA Wizard Pro 2012, .NET Frame Work 3.5 SP1,Selenium .

Celgene Corporate, Summit NJ Apr 2008 - Mar 2012

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases.

Project Title: Inform EDC, Jreview, Central Coding,Central Lab, iMedidata Rave, ARISg, Seibel e Clinical.

Client: Celgene

Role: Sr. QA/Validation Analyst.

Description

JReview : to view, create, print, and interact with objects like graphs,reports, patient profiles, shift tables,crosstabs etc .

Central Coding : customizable coding and dictionary management software to help alleviate the challenge of coding medical terms across clinical trial studies.

IMedidata Rave :for capturing, managing and reporting clinical research data supporting both electronic data capture (EDC) and clinical data management systems (CDMS) functionality.

Inform EDC Electronic Data Capture of clinical trial data helps to enter data into electronic Case Report Forms (eCRFs.).Creates, resolves and track queries and lets user view ad hoc Reports.

ARISg Global : a standard Java based web application for managing Adverse Events Reporting System.

Siebel e-Clinical : web application for setting up and managing Clinical Trials.

Livelink :Corporate level Document Management System for managing electronic records and project life cycle documents such as SOP, Work Practice, Validation Plan, Validation Summary Report and other life cycle documents based on OpenText.

Responsibilities

Developed Compliance Assessment and 21 CFR Compliance Check List for the Applications.

Developed and designed the validation plan and testing protocols for computer-automated systems for the above applications.

Reviewed and analyzed Business/Functional Requirements, Technical Specifications and documented Test Requirements.

Developed Testing strategy and testing approach of above cited applications, defining pre-condition and post-condition for different Test Case scenarios.

Interacted with Business Analysts/Users/Developers for collecting Requirements, test scenarios, defects and resolution etc. Actively participated in various status meetings and weekly meetings.

Reviewed the Requirements and the Use Cases in SRS document converting Business Requirements / Rules into test scenarios and lead the work of authoring manual, semi-automated test cases / test scripts.

Developed Requirements Traceability Matrix (RTM) to track requirements against Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Participated with team in delivering timely communications with regulatory agencies.

Participated in systems criticality assessment (SCA) and Functional Risk assessment(FRA) and authored Systems Design specification (DS),Functional Requirement Specification (FRS), and User Requirement Specification (URS).

Authored Test Cases, set up and preparation of Test Data for the applications.

Verified Pre & post-testing documentation in compliance with 21 CFR Part 11 guidelines.

Lead the work of a team of testers for completing System Testing and validation of Clinical, Drug Safety applications.

Coordinated the work Schedule and Project Status between the team and the Manager.

Database testing experience with SQL queries for searching, creating and updating test data, validating data migration using TOAD and or True Compare.

Track and investigate issue, coordination with Business users, System analysts.

Used Quality Center and Quick Test Pro QTP 9.2 for managing the Test Process for the Applications.

Created Automated Test Scripts using QTP 9.2.

Authored and executed IVRS (Interactive Voice Response) scripts.

Performed Data Integration Testing for IVRS, Central Coding and Central Labs.

Used MS Visio 2000 for creating Work Flow Diagrams and Business Processes.

Supervised UAT and final acceptance by users.

Authored and executed SQL Queries for data validation of SAS datasets for Clinical Trials Management System.

UAT coordination resolution of issues and signing off.

Performed edit check peer review for developers and Data Managers.

Reviewed various Change requests, eCRF Specifications, UAT scripts.

Authored Validation Plans, Validation Summary Reports and other project deliverables, project status reports including test metrics.

Created worflows in LIMS

Tested various livelink, web and adhoc Reports.

Environment:Open Text’s Livelink v9.5 SP1, Mercury Quality Center 9.0/10, MS Word, MS Excel, QTP 9.2, Oracle 9i, TOAD/SQL, JReview9.1.1, IReview,InForm EDC, IMedidata Rave, ARISg, Siebel e-Clinical, Central Coding, SAS, Adobe Acrobat 7.0,Central Designer/Inform 4.6 SP2a, Central Labs,LIMS.

Almac Clinical Technologies, Yardley PA Apr 2007 – Feb 2008

Almac Clinical Technologies specializes in interactive technology and service solutions that advance human health by increasing the quality and efficiency of the clinical trial process.

Project Title: IVRS Testing

Client: Almac

Role: Sr. QA/Validation Analyst.

Description: The Application consists of integrated suite of technology solutions that include Interactive Voice Response System (IVRS) and Interactive Voice and Web Response Systems (IXRS) for modules like patient Screening, Randomization, Subsequent Assignment, Tracking Clinical Supply and Inventory Management etc .

Responsibilities

Authored Test cases for Web Reports (Business Objects) and executed backend testing.

Authored various UAT and LAT plans for applications.

Authored and executed various test scripts for Data Transfers, Alerts, BizTalk Server Data Transfers, Drug Management (Drug Ordering and Labeling)/IIR(Internal Inventory Report) /ADO(Automated Drug Ordering) and IVRS integration modules.

Executed database, functional and regression testing using QTP 9.1.

Provided regular progress reports to Team Lead.

Attended FRS, URS and Test Case review meetings with Project Managers and Developers.

Environment: IVRS,MS Access, Business Objects, Clear Quest, SQL Server, BizTalk Server, Visual Basic, Stylus Visual Voice 3.01, Microsoft Windows XP, Inter-Tel Access – 4.3, QTP9.1,MS Word 2003, MS Excel 2003,Master Control, Project Tracker.

American Home Mortgage (AHM), Melville NY Jun 2006 - Apr 2007

AHM is one of the nation's top mortgage lenders.

Project Title: UNIFI to Web

Client: AHM

Role: Sr. QA Analyst.

Description: Redesigning of an existing Client Server Application developed in UNIFI/PROGRESS to a Web Application for providing end to end Loan application processing solution to the Correspondent & Wholesale Lending Division for loans like Arm, BuyDowns, Conventional, Jumbo, FHA, MTA, Choice, MIP, Interest only, Government, Conforming, Purchase, Refinance, helocs etc .

Responsibilities

Developed and Implemented Test Plans using Mercury Quality Center 9.0.

Created/Executed/Maintained manual and automation Test Scripts using QTP 9.0.

Created and executed regression test scripts to test end to end Loan Processing.

Created and executed test cases to test web integration with external applications/Web Sites like Fannie Mac Desktop Originator Website (DU/DO) for Importing DU case file and DU findings.

Performed Database testing.

Attended test plan meetings with Business Analysts and Developers.

Attended weekly meetings with Managers, Business Analysts and Developers for defect resolution and provided regular progress reports.

Environment: Quality Center 9.0, QTP 9.0, Load Runner 7.8, UNIFI/ SQL Progress, HTML, JavaScript, ASP.NET, Windows XP.

PHH Mortgage, Moorestown NJ Oct 2005 - Jun 2006

PHH is a full-service lender in relationship-driven mortgage banking & provides full-service capabilities for originating, processing, closing, servicing loans & various other mortgage products.

Project Title: CA$H, PHHORCE, Galaxy, FSMS Closing, Wave, Loan Span and iDesk.

Client: PHH Mortgage

Role: QA Analyst.

Description: Origination, Processing, and Closing of different types of loans like MBS Purchase, Refinance, Heloc, Piggyback, Landscape etc is done using these various applications .

Responsibilities

Performed end to end testing of different client server and web applications.

Performed functional testing, data integrity testing, regression testing, and smoke testing.

Worked with developers to resolve issues logged in Team Track.

Performed Regression testing of different loan scenarios using QTP 8.0.

Attended approach meetings with Business Analysts and Developers.

Load testing using Load Runner scripts to emulate users &monitor systems performance.

Load Tested applications for Response Time & Simultaneous Transaction HTTP protocol .

Environment: Test Director 8.0, QTP 8.0, Load Runner, Team Track,JSP, J2EE, EJB, Java Script, Power builder, Sybase SQL Server 11.x, Oracle9.0, Windows NT, Windows XP.

Marsh Inc., Hoboken NJ Mar 2005 - Oct 2005

Marsh is a Global leader in insurance broking and risk management.

Project Title: Human Resources and Information System (HRIS)

Client: Marsh

Role: QA Analyst.

Description:Web Global application designed & developed by Human Resources & Information System HRIS group of Marsh for its US & International employees to provide People Soft functionality over the web.

Responsibilities

Created and implemented testing strategies.

Created Manual and Automation test cases.

Tracked Defects and discussed Issues in Client Status Meetings.

Involved in defining Scope of upcoming versions and their Pre-Release testing.

Created Defect Analysis Reports using Test Director.

Analyzed/validated checks at the code level on data using TOAD.

Involved in stress and performance testing using Load Runner.

Environment: VB.Net, ASP.Net, Visual Source Safe, Oracle 8i, TOAD, Test Director 7.6, Load Runner.

British Airways, Heathrow UK Sep 1998 - Jun 2001

British Airways is one of the leading airlines across the Globe.

Project Title: Revenue Management System

Client: British Airways

Role: Programmer/Tester.

Description: The application entitles various Reward Schemes to BA frequent flyers & is used by BA RMEs.

Responsibilities

Involved in Requirement Gathering and preparing High level design document.

Performed GUI Testing using Win Runner.

Authored test plans and test cases.

Performed volume testing on multiple clients using Load Runner.

Participated in weekly project status meetings and updated the testing progress.

Maintained different releases of the application.

Created code for Front-End Forms, Middle Ware and Back End scripts.

Implemented the Design and Testing of procedures in Java 2,VB5, C, Pro C and PL/SQL.

Worked as offshore Coordinator.

Performed debugging and bug fixing of the code.

Environment: Oracle 8i, Visual Basic 5.0, Windows 2000/NT, SQL, Win Runner 6.0, Test Director 6.0, PVCS Bug Tracker, Load Runner, Java, C, ProC, PL/SQL, Oracle and UNIX.

ITCOM Software Inc, India Aug 1996 – Mar 1998

ITCOM provides a range of services to its clients including building & maintaining websites for them & helping them to transition their business from paper based model to electronic record keeping.

Project Title: New Admissions Trend Prediction.

Client: DAV School

Role: Programmer.

Description: To predict number of admissions expected for a new academic session based on the previous trends.

Responsibilities

Involved in Requirement Analysis, design, development and testing phases.

Designed and coded procedures & Forms in Visual Basic 5.0 with Oracle as Back End.

Performed manual testing and maintained documentation for the defects.

Designed code for generating bills using Crystal Reports for the new customers.

Environment: Visual Basic 5.0, Oracle, SQL, Windows NT, Excel, Crystal Reports.

Education –

Diploma in Business Management, IGNOU, India.

Bachelor of Engineering in Computer Science, Pune University, India.

Certifications-

Certificate course in Visual Basic.

Certificate course in Automated Testing Tools &Quality Assurance Process using Load Runner, Win Runner, QTP.

Quality Management System (SEI CMM Level 5).

Brain Bench Certified in Software Quality Assurance and Software Testing.

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