SUMMARY

• Over seven years of professional experience in Validation, Quality Assurance and Technical Writing.
• Worked extensively on testing of web and server based application in the Pharmacy and Healthcare Domain.
• Have extensive experience using HP QC for manual testing and HP QTP for automated testing.
• A committed, self - motivated and detail oriented individual, who works well in teams, has excellent communication and interpersonal skills, and exceptional analytic and problem solving skills.
• Strong understanding of 21 CFR Part 11 drug cGxP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Strong knowledge of all phases of Software Development Life Cycle (SDLC), and experience working in Agile Scrum, RUP and Waterfall environments.
• Excellent understanding of Software Validation Lifecycle (SVLC), and QA methodologies.
• Experience in STLC from requirement/design review, to the test reporting phase
• Expertise in preparing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance with FDA rules and regulations.
• Comprehensive knowledge and extensive experience in preparing and reviewing Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM)
• Proficient in developing Test Plan Documents, Test Scenarios, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards
• Working experience in computer system validation in compliance with FDA regulations, including Laboratory Information Management System (LIMS), Scientific Data Management System (SDMS), and Adverse Event Reporting System (AERS- Argus)
• Skilled in developing Standard Operating Procedures (SOP's), policies and working instructions to comply with FDA regulations.
• Experience with Laboratory Information Management System (LIMS), Adverse Events Reporting Systems (AERS), Change Control Management System and Enterprise Document Management System (EDMS)
• Aptitude in System testing: performed manual testing using HP Quality Center (QC) and automated testing.
• Created test Data based on business rules and processes in MS Excel.
• Performed Black box and White box tests, and specific expertise on Smoke, System Integration, Functional, Sanity, Regression, and Performance Back End Testing.
• Expertise in functional and GUI testing of web applications
• Through knowledge of HIPAA standards, and EDI transactions such as 834, 835, 837, 270, 271.
• Proficient in mapping the traceability from technical specifications and requirements to test scenarios and test steps using Rational ReqPro and Quality Center (QC).
• Thorough understanding of UML diagrams, and experience creating UML Diagrams in MS Visio
• Experience in training User Acceptance Testing (UAT) team and assisted in creating UAT Test case.
• Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.
• Trained as a Six Sigma Green Belt, and implanted its techniques in Root Cause Analysis of defects.

TECHNICAL SKILLS

Operating Systems: MS Windows, Mac, Unix

Testing and Defect tracking tools: HP Quality Center, HP ALM, HP QTP, Rational ClearQuest

Databases: SQL, SQL Server, MS Access, Oracle

Business and Data Modeling tools: MS Excel, MS Outlook, MS Project, MS Visio, Rational Requisite Pro, UML, Oracle Argus and Empirica safety/signaling database system

SDLC Methodologies: AGILE, RUP, WATERFALL

Languages: HTML, SQL, XML, Visual Basic

PROFESSIONAL EXPERIENCE

Confidential, Rahway NJ

Sr. Validation/Quality Assurance Analyst

Responsibilities:

• Interacted with Business and Information Technology personnel's to gather the requirements and create the Requirements/Configuration Specification for Argus Safety System.
• Developed and implemented complete software validation and quality assurance programs including Standard Operating Procedure (SOPs) governing validation activities; templates for validation related documentation such as validation protocol and plans, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
• Developed Standard Operating Procedures referring CFR Part 210, 211.
• Performed a series of tests including Black Box, Smoke, Regression, Usability, Integration, System, and User Acceptance Testing.
• Performed manual testing for each releases and prepared test case execution reports, defect status reports from HP Quality Center.
• Authored Validation Master Plan, Summary Reports, GxP Assessment Documents, Trace Matrices, Change Plan and Summary and Test Scripts for systems such as Argus and Empirica signalling system
• Executed test cases, logged defects and tracked defects till closure using HP Quality Center/ALM.
• Used Data Driven and Keyword driven framework to develop HP QTP automation test scripts.
• Prepared the test execution report, Bug fixing report documentation for the future reference.
• Conducted weekly Review meetings to discuss the status of the project and communicated with developers for appropriate handling of the defects and their timely resolution.

Confidential, Westbury NY

Validation Analyst

Responsibilities:

• Acquired and documented the business requirements.
• Prepared Validation Master Plan (VMP) for validating LIMS.
• Agile framework was followed in SDLC and Validation Lifecycle VLC.
• Analysed Business and Functional specifications and interacted with Business analyst and Subject matter experts for formulation of Test Strategy, Test Scenario, Test Plan Document, and test cases.
• Responsible for analysing and reviewing validation deliverables like User Requirement specification and Functional requirement Specification.
• Analysed and reviewed IQ, OQ, and PQ protocols.
• Developed and reviewed test scripts and test cases for automated and regression testing.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in HP Quality Center and reported the defects.
• Generated Validation Summary Report to summarize and document all validation activities.
• Developed and reviewed Standard Operating Procedures (SOPs), Requirement Traceability Matrix and Work Instruction for various functionalities of the system.
• Used Defect Management grid of Quality Center in logging and analysing defects.
• Analysed test scripts to ensure all functionalities were covered within the compliance of 21 CFR Part 11.
• Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.
• Performed user acceptance testing (UAT) to the check the various functionalities of LIMS. .
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.
• Responsible for writing SQL Queries that ensured data was populated in the appropriate fields

Confidential, Santa Fe, NM

Validation Analyst

Responsibilities:

• As a member of Computer Systems Validation team, responsible for documenting and reviewing all the validation deliverables as part of validation package.
• Authored VMP (Validation Master Plan) with risk based approach for validation.
• Responsible for developing, analyzing and reviewing validation deliverables like User Requirement specification (URS) and Functional requirement Specification (FRS).
• Responsibilities also includes system qualification, assist in the design, analysis and approval of IQ, OQ, and PQ protocol scripts
• Developed Test Plan, Test Strategy, Test Scenarios, and Test cases for functional, System Integration, Regression, Security, and UAT testing.
• Designed, developed and implemented Test Plans using the detailed business requirements document (BRD).
• Responsible for mapping of IQ to Design Specification, OQ to Functional Specification and PQ to URS
• Communicated validation approach and requirements to team and business owner using MS PowerPoint.
• Extensively involved in Defect tracking, reviewing and analyzing and reporting test result using HP Quality Center.
• Provide support for validation sections of regulatory submissions.
• Made sure all the documentation and records met 21 CFR Part 11 requirements.
• Submitting daily and weekly status reports to the manager and performed timely escalations to the management
• Performed manual testing in HP QC, executed test cases and logged defects.
• Used HP QTP to develop automated test cases for Regression testing of functionality and GUI’s of the application, enhanced the test scripts with VBScript for dynamic data parameterization.
• Performed Root Cause Analysis of defects, reported findings to the Validation lead and followed through to resolution and final testing.

Confidential, New York, NY

Quality Analyst

Responsibilities:

• Assisted in the development of a test strategy, and interacted with Business Users and QA lead to obtain authorization for the Test Plan document.
• Reviewed the functional specification document (FSD), and interacted with the Business Analysis team to further understand 4010 and 5010 HIPAA EDI Transactions such as 270, 271, 834, 835, and 837.
• Involved in Functional, system, Integration, and security testing for all transaction types.
• Analyzed requirements and prepared test data for positive and negative test cases for functional testing and security testing.
• Developed and executed manual Test Cases in Quality Center (QC).
• Categorized test cases based on their business requirements in Rational ReqPro.
• Collected the Test Data in the pre-testing phase for positive and negative scenarios
• Used QC to track defects through the entire Bug Life Cycle.
• Tested the Members, Providers, Facets Workflow, and Claims in Facets GUI
• Executed SQL queries to verify the transaction codes that were generated in the new 5010 format.
• Provided Test and defect status reports.
• Assisted the UAT team with developing test cases.
• Project was implemented using Waterfall methodology.