Test Cases Management
Resume:
Anita Trehan
Princeton, NJ ***40
************@*******.***
Professional Summary
More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis; Data Analysis and Management; Software Application Testing; Document Management; Change Control and Release Management; FDA Compliance Verification and Validation; Quality Assurance Processes and Methodologies; Developing Testing Strategies and Test Plans; Test Scenarios and executing Test Cases for carrying out End to End Testing; Regression Testing; Systems and Integration Testing; User Acceptance Testing and Usability Testing for Business Applications and Web Services.
Proficient in Agile Methodology and various Testing phases for Clinical Trials for different Pharmaceutical clients including GUI Testing, Functionality Testing, Security Testing, System Testing, Regression Testing, Integration Testing, Back End Testing (Oracle tables manipulation- using SQL), FDA 21-CFR Part 11 rules and regulations and under GMP environment.
Besides I have over 14 years of IT experience in the analysis; design; development and implementation of IBM Mainframe and Oracle RDBMS based Enterprise Business Applications and ERP Packaged Solution in the Corporate Systems Management Division for India’s leading Industrial group
Technical Skills:
Training : QTP, WinRunner, LoadRunner,
Tools and Testing Software: PowerPoint, Word, Excel, Master Control, Rational Robot, FDA rule 21-CFR Part 11
Tracking Tool: Test Director, Rational Clear Quest, ServiceNow, Quality Center
Programming Languages: Cobol, SQL, Oracle
Databases: Oracle 8i, SQL Server 6.5 / 7.0, MS Access2000
Operating Systems: UNIX, Windows NT/2000, Solaris 8.
Protocols: TCP, UDP, SMTP
Education:
Bachelor's Degree in Science, Maharishi Dayanand University, Rohtak, Haryana, India.
M.B.A, Indira Gandhi National Open University, Delhi, India.
Major: Finance and Systems.
Personal: US Citizen
Professional Experience
Clinical Programmer II
Chiltern International Ltd., 1016 West Ninth Ave,
King of Prussia, PA, 19406 Apr 2015 – till date
Conduct testing activities for different clients, in support of clinical trials.
Responsible for making and reviewing testing documentation like Testing Expectation(TEEX) document, Test Plan, set up data and writing Test Cases and follows the process of client UAT.
Engaged in setting up of Clinical Trails data.
Created Test Cases, Test Scenarios, and Traceability matrix to cover business functionality.
Creation of study reports to analyze the data of the study.
Created all bugs in Merit- Dashboard and loading clinical trial documents in Veeva/Epic tool.
Coordinated Test Plan meeting with all stake holders.
Ensure that all protocols for the studies have been validated under FDA 21 CFR Part 11, Gxp regulations and guidelines – predicate rules defined in SOPs (standard Operating Procedures) and WIs (working instructions).
Review of documents generated by the team members.
Ensure the validation group to meet all requirements of documentation and responses to Audit findings
Managing all protocols with different clients.
Senior Quality Assurance Analysts
Aetea Information Technology, Blue Bell, PA
Express Script, Blue Bell, PA Aug-2014 - Dec-2015
Conduct testing activities for a EDC project of different clients, in support of a Phase II clinical Trials.
Created test cases based on user requirements.
Executed test scripts, originate defects and track them till they deem get fixed. Used TFS for reporting defects.
Review completed test scripts along with all evidences of other QA personnel in the team to ensure that all requirements are met and properly documented as per UBC procedure.
Assist in the training to other QA staff.
Radiant Systems Inc, NJ
Quality Control in Johnson & Johnson, Raritan, NJ Apr-2014 - Jul 2014
Roles and responsibilities:
Main responsibility is to see online EVA and XP storage migration documents are as per Compliance and QC.
Participate in the meetings to drive series of process improvements for online EVA & XP migration project.
Follow up with engineers for documents which are of high quality per compliance.
Participated in the reviewing and finalizing templates for EVA and XP Migration.
Create change control tickets for online EVA and XP projects in ServiceNow tool for server migration project.
Follow up with engineers for completing documents for change control.
Responsible for the closing Change Request in ServiceNow tool.
US Tech Solutions, NJ
Business Analysts in Abbott Labs Point of care Oct-2013 – Feb-2014
Roles and responsibilities:
Main responsibility is to implement Change Control Software System to automate paper-based Change Control/Change Management Processes in Regulated Environments & assure Enhancement in Productivity.
Analyze the current processes of Abbott Lab Point of care and carried out gap analysis to finalize future state business processes.
Gather Requirements to implement Change Control Process & Design Control Process after meeting with end users based in Princeton and Ottawa.
Developed Business Process work flows using MS-Visio for Master Control Team.
Conducted few sessions with end users to finalize business processes and work flows.
Developed URS for web based system to capture business process changes for Master Control System.
Organized meetings with Master Control team and helping end users to understand how master control works & helped Abbott business users to automate business process and achieve paperless environment for the QA department.
Help the validation team in creating a knowledge repository for validated documents.
Robert Half Technology, NJ May 2013 – Sep-2013
Senior QA Analyst in Deloitte
Roles and responsibilities:
The Engagement Management System (EMS) developed by Deloitte is a leading edge system that gives practitioners the capability to create, conduct, and document an audit to meet the unique needs of every client engagement.
Performed testing the functionality of Engagement Management System (EMS)
Worked closely with all members of the software development team to test functional and business requirements and to ensure high quality deliverables.
Analyzed business requirements and carried out URS review and provided feedback to the team.
Performed Functional and Regression Testing for major builds 3.1 and 3.2.
Tested both releases under Agile methodology.
Involved in gathering and documenting User Requirements team approval. Used Quality Center tool to write and execute Test Cases.
Created Test Cases and Test Scenarios to cover business functionality, like procedures, risks and common tools like Tick Mark, Cross Reference, and Review Notes and mapped them into QC requirements module with the project requirements.
Developed and executed manual script based Test Scripts.
Created Engagement files and sync them with server and Peer to Peer to test the functionality for data movement.
Recorded defects and coordinated resolution with development team and functional leads.
Utilized TFS and Rational Clear Quest for Defect Tracking and maintained Defect Repository and followed Defect Life Cycle until it was closed
Environment: Quality Center 10.0, SQL Server 2008, Rational Clear Quest, Team foundation server (TFS).
Almac Clinical Technologies, PA May 2006 -2013
Senior Systems Analyst
Roles and responsibilities:
Responsible for establishing Clinical Trial frame work; conducting Requirement analysis and recommending best practices; Participating in Impact Analysis and FRS review; Writing and conducting review of Test cases. Set up studies in Test environment from the latest base line; set up data for the study; execution of Test cases; Developing internal User Acceptance Test and Client User Acceptance Test Plan and data set up accordingly. Responsible for tracking till execution is done by Project Specialist or by client.
Additional responsibilities are to work with management to develop effective ways to increase system reliability and quality
Writing and executing test cases for all modules of IVRS/IXRS Study application and products supporting Pharmaceutical Clinical Services Organization.
Maintain Clinical Trials Study Documents in Master Control Tool.
Developed and executed manual test scripts.
Perform functional testing, integration testing and user acceptance testing.
Performed black and white box testing and regression testing
Responsible for documenting test results in test plan after executing test scripts.
Responsible for keeping all error request generation in IBM Clear Quest till the time they get resolved.
Involved to convert complex functionality into small Visio diagrams to have better understanding for the team.
Ensure Data Setup, Writing and execution of all IXRS modules and Drug Management.
Ensure correct testing of Internal Inventory and other subsequent build reports. .
Ensure the validation group to meet all requirements of documentation and responses to Audit findings.
Ensure full understanding of and compliance to, the ALMAC SDLC Processes.
Ensure that all protocols for the studies have been validated under FDA 21 CFR Part 11, Gxp regulations and guidelines – predicate rules defined in SOPs (standard Operating Procedures) and WIs (working instructions).
Mentor subordinates and new employees until deemed trained.
Manage and prioritize work load and escalate conflicting schedules to Group leaders.
Participate in client audits and assist Quality Assurance group with responses to audit findings.
Ensure communication of Project test status to Project team members and for the timely delivery of all test deliverables (Internal and External).
To ensure improve quality for core mods applications for different clients.
Other responsibilities assigned by the Management like Coordinate Project test effort when multiple test analysts are on the team.
Ensure Unit Testing using SQL before release comes to test. Good knowledge of SQL, and executed SQL statements
Successfully engage in multiple initiatives simultaneously i.e. modifying/creating SOPs and WIs.
Proactively communicate and collaborate with external and internal teams to analyze information needs and functional requirements and deliver URS/BRS, test cases, test plan, and Traceability Matrix.
Ensure to test application with test scripts and Validation reports under Agile methodology.
Responsible for activities like tracking, co-ordination, and deadlines of the projects.
Accenture, New Jersey Apr-2004 – April 2006
Data Management Analyst
Roles and Responsibilities:
Responsible for developing Requirement Specification, Critical Release Plans, Test Plans across IMPACT, e-DAD and R-IPET Projects for different releases as per NAVIGO till production to release memo.
Responsible for Unit Testing and System Testing of different releases of IMPACT.
Responsible for Integration Testing between SAP and IMPACT Vendor Management System.
Act as System Test Lead for IMPACT 3.3.5 release in Oracle Environment for Financial, Planning and Monitoring Modules and IMPACT.
Wrote all System Test Scripts and data setup.
Maintain Test tracker for tracking all the activities of System Testing.
Responsible for writing Critical Release Plan, Traceability and Test Summary Report to incorporate all testing strategies.
Wrote & run SQL queries for Verification against online values database.
Environment: Oracle 9i application server, 10g server and UNIX.
Wyeth, Collegeville, PA Feb 2004 – Apr 2004
Validation Specialist
Wyeth Research in conjunction with O3Media and Alliance Consulting developed the TOPIQ (Training and Operating Procedure Interactive Quiz) application as a web based quiz-taking application. The application was expanded the user community to other organizations within Wyeth. This system creates and maintains the quizzes. The end user interface which is used to deliver and grade user quizzes.
Roles and Responsibilities:
Responsible for updating User Requirement Document to incorporate 21 CFR PART 11 Security Rules.
Responsible for updating Design Document.
Responsible for writing IQ/PQ protocols.
Writing and execution of OQ Test Scripts for TOPIQ system.
Responsible for creating Traceability matrix for requirements with test cases.
Responsible for writing Validation Plan and Validation summary report.
Responsible for making Risk Analysis report after discussing with the end users.
Perform Guerilla System testing as per the requirement.
Wrote & run SQL queries for Verification against online values database manually.
Involved in updating SDLC document to show the System Life Cycle of TOPIQ system from Initiation thru retirement stage.
Involved in updating the procedure for platform qualification to reside all validation document for TOPIQ.
Environment: Oracle 9i Application Server, UNIX
Aventis, Bridgewater, NJ Sep 2003 – Jan 2004
Validation Specialist
The Global Commercial Operations Internet Framework (GCOIF) was developed in order to bring consistency, standardization, increase efficiencies with the development and maintenance for Internet site deployments. As part of the web sites migration effort, several features that are common across many of the sites were identified and developed as a set of re-usable components under a standard framework.
Roles and Responsibilities:
Executed Validation Test Scripts for Documentum for different servers in global locations.
Responsible for verifying test results on different servers.
Responsible for designing, developing, and updating documents like User Requirement Document, Test Plan, Transition Plan, Technical Design Document, Test Cases, Requirement Matrix for “Contact Us” portion of the website of Aventis.
Schering - Plough, NJ March 2003 – Aug 2003
Systems Analyst
The Schering Plough Corporate has implemented Safety & Environmental Affairs Tracking System (SEATS). This is an application, which maintains all corrective actions through closure. Corrective Actions are identified during internal / external audits. The objective of this project is to implement a web-based automated system that standardizes data capture, identifies required actions, assigns responsibility and due date, allows appropriate approvals, provides reporting capabilities, implements security among users, and provides management with the capability to track and trend required actions by various criteria.
Roles and Responsibilities:
As a Systems Analyst, carried out Analysis of User Requirements.
Tested SEATS application for Corporate Audit and Non-Corporate Audit.
Tested Workflow for Events, Findings and Corrective Action Records for Corporate Audit.
Tested Workflow for Events, Corrective Actions and Required Action Records for Non-Corporate Audit.
Used Test Director for managing User Requirements, Test Scripts and reporting defects.
Used WinRunner for learning windows and objects and names of these windows and objects were referred to estimate time frame to write test scripts for this project.
Prepared Test Plans, Test Strategy and Executive Summary documents of the project.
Novartis Pharmaceuticals, NJ Oct 2002 – Feb 2003
Systems Analyst
As a part of CFR 21 Part 11 compliance program, Novartis has developed VALTRAC, an application which maintains an inventory of validation documentation and their statuses. As GxP and non-GxP assets require various types of validation activities, tracking of these validation activities has historically been accomplished through a variety of spreadsheets and lists. Validation is designed to track activities, in order to provide validation status of Objects & Documents e.g., Methods, Processes, and Software Validations, Installation Qualification (IQ), Operational Qualification (OQ), Procedure Qualification (PQ) as part of GXP Part 11 Assessment. Novartis IT group is responsible for Testing CaliberRM 4.0 Tool & Starteam Elite 5.0 Tool for CFR 21 Part 11compliance.
Roles and Responsibilities:
As a Systems Analyst, carried out Analysis of User Requirements.
Wrote unit test plan & acceptance test plan during the Analysis, Design & Development as part of SDLC of Application.
Test the VALTRAC application.
Lead a team for 2 for Maintained Accuracy & confidentiality of Clinical Data.
Writing Documents and Scripts in accordance to the FDA Validation Standards.
Utilized CaliberRM 4.0 to write Test Script for VALTRAC application.
Insisted team to document validation processes of VALTRAC application, which matches with FDA regulations particularly 21 CFR Part 11.
As a Systems Analyst carried out Analysis of User Requirements for CaliberRM 4.0.
Prepared User Requirement Specifications (URS) document of CaliberRM 4.0 and got approved by different Novartis IT Project Management Groups like CSV (Computer System Validation).
Written Protocols including PQ, IQ and OQ
Written Test Scripts to test the CaliberRM 4.0 tool and showed the management that this tool is best for them to gather requirements and test the application.
Submitted Weekly Progress Reports to the Project Manager.
Carried out Analysis of User Requirements for StarTeam Elite 5.
Prepared User Requirement Specifications (URS) document of Starteam Elite 5 and got approved by different Novartis IT Project Management Groups.
Written Test Script for Starteam Elite 5 in CaliberRM 4.0 and interfaces to other Tools like CaliberRM 4.0
Carried out validation and Disaster Recovery to ensure Data base integrity of VALTRAC Application.
Responsible for recovery of Oracle Data from backup as Sun Solaris crashed and wrote SQL Scripts to test the area of interest
Environment: Oracle 9i Application Server, Sun Solaris, Oracle Forms 6, CaliberRM 4.0, Starteam Elite 5, Clinical Data.
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