SUMMARY

• Over 14 years of diverse experience in Quality Assurance, testing and validation and over 10 years of diverse experience in Medical Device, Pharmaceutical, Bio - Tech industries.
• Diverse experience in Medical Device, Biotech and Pharmaceutical companies in GCP, GLP and GMP environments.
• Expertise in qualifying various GMP, GCP, and GLP systems such as CTMS, Clinical Trial Management System, CDC Clinical Data Capture, CDMS Clinical Data Management System, Customer Order Entry, shipping and handling applications, as well as training systems.
• Experienced in working in eLAB, SAP, Siebel’s CRM Life Science, Confidential HR, CTMS, Adverse Events, CAPA, Documentum, Kofax, eLearn Online Training applications.
• Strong experience in writing and reviewing Validation Master Plan, IQ, OQ and PQ protocol, trace matrix, Combined Risk Assessment and FMEA (Failure Mode Effect Analysis), Test Summary Report, System Design Specifications, User and Functional Requirement Specifications, use cases and SOP’s.
• Extensive experience on test scripting, manual and automated test execution and documentation as per FDA guidelines.
• Strong working knowledge of GAMP 4, 21 CFR Part 11, 210, 211, 820 and PDA18.
• Strong understanding of EMEA, FDA, GxP, HC, ICH, ISO, MHLW, MHRA, PDMA, 21 CFR Part 210, 211, 11,guidelines.
• Extensive experience performing Functional, Integration, Load/Performance, UAT and Regression testing using Test Automation tools such as Load Runner, Test Director, Rational Requisite Pro.
• Experienced in consolidating Final Validation package, which includes validation documents and production documentations, and thus coordinating with QC, Regulatory, Deployment and IT teams.
• Excellent professional acumen to work independently and also as a team member.

PROFESSIONAL EXPERIENCE

Confidential

Validation Analyst

Responsibilities:

• Performed software validation for several upgrade Projects for IQS (Integrated Quality System) that deals with lifecycle of quality records produced during manufacturing and release of clinical and commercial active pharmaceutical ingredient (API) as well as clinical drug product.
• Worked with Business Teams to author several change request document that truly reflects user needs. Authored URS and FRS that are aligned with user requirements.
• Authored software design specifications, report specifications, validation protocol, test scripts, test summary reports, traceability matrix documents for several enhancement projects within IQS.
• Performed IQ, OQ and PQ testing for all enhancements projects.
• Identified several key defects that helped development team to build more robust system.

Environment: Confidential .NET, Windows NT Client/Server, IE 7,8, Win Vista, MS-Office.

Confidential

Validation Analyst

Responsibilities:

• Performed software validation for several SAP Upgrade Projects and GCTD Application (Common Technical Document) and its integration with Documentum which was developed and implement for Regulatory Publishing groups for South San Francisco and Nutley, New Jersey.
• Developed several Executable Functional Specification for multiple releases during the Agile development process.
• Wrote OQ Protocol that included several OQ scripts and Regression scripts, dry ran and executed them in validated environments.
• Wrote PQ Protocol that included several PQ scripts based on user roles and business processes of every Publishing groups.
• Wrote several documents including change request document, risk analysis report, test summary report and Trace-Matrix and followed their approvals process as per SOPs.
• Performed Sanity Test for all builds that was released.
• Identified several key defects that helped development team to build more robust system.

Environment: SAP CE Netweaver,SAP SRM, Confidential .NET, Documentum, Windows NT Client/Server, Sun Solaris and Win NT, MS-Office.

Confidential

Validation Analyst

Responsibilities:

• Performed OQ and PQ validation for pMMS (Material Management System) ERP system for modules Order to Purchase Requisition, Trasmitting PO to vendor, Goods Reeipt, Invoice Receipts and Acounts Payable Run.
• Performed several M&E (Maintenance and Enhancement) projects for Phillips Medical’s Infrastructure validation that included SSO Single-Sign-On Architecture, validation, user rights, and permissions as per 21 CFR Part 11 regulations.
• Wrote requirements as part of the OQ for Phillips Medical and Invitrogen for their customized features in CTMS applications. This included Study Management, Protocol Management, Site Management, Adverse Event, Complaint Reporting, CAPA Management and Regulatory Reporting.
• Developed MVP, IQ and OQ protocols and followed as per PDA18 guidelines and 21 CFR Part 11 regulations.
• Wrote several documents including change request document, risk analysis report, test summary report and Trace-Matrix and followed their approvals process as per SOPs.
• Used Quality Test Center for requirement, test planning and test management and used Test Director for defect tracking.
• Actively participated in requirements phase, design reviews, testing activities including unit testing, system testing, and integration testing.

Environment: J2EE, Confidential -Siebel 8.0, Confidential Quality Center Test Director, Load Runner, Windows NT Client/Server, Sun Solaris and Win NT, ClearQuest,, MS-Office.

Sr. Validation Test Engineer

Responsibilities:

• Lead and supported SQA activities for Confidential ’s LMS Learning Management System upgrade that included Single-Sign-on capability of LMS within Confidential ’s network, Sequencing of Learning Events, Direct Linking capability of Courses and Content Lockout.
• Responsible for performing SIA System Impact Assessment, CCA Component Criticality Assessment and conducting PHA scores to determine level of Severity and Priority.
• Authored several documents that included VPP Validation Project Plan, Traceability Matrix, OQ Test Scripts and several risk assessment documents.
• Worked with business analysts, users and developers to design suite of test scenarios that could be utilized during unit, OQ, PQ and User Acceptance Testing and also assisted Development team in code acceptance testing.

Environment: Plateau LMS, J2EE, Windows NT Client/Server, Sun Solaris and Win NT, MS-Office.

Validation Analyst

Responsibilities:

• Perormed OQ and PQ for Invitrogen's SOMR (Sales Order Management Reporting System) on SAP ystem using Query Reporting Tools for Master Data Objects such as as Customers,Vendors,Materials, Conditions and Credit Limits and Data Objects such as Sales orders
• Deliveries, Billing documents and Purchase orders.
• Performed IQ, OQ and PQ for CVT’s Clinical Trial Management system implementation on Confidential -Siebel CRM 8.0.
• Performed IQ testing which included migration testing from Siebel 7.8 eClinical interface to Confidential -Siebel 8.0.
• Wrote several protocols as part of OQ for CVT and Invitrogen for their customized features in CTMS applications.
• Developed MVP, IQ and OQ protocols and followed as per PDA18 guidelines and 21 CFR Part 11 regulations.
• Wrote change request, risk analysis report, test summary report and Trace-Matrix and followed their approvals process as per SOPs.
• Used Quality Test Center for requirement, test planning and test management and used Test Director for defect tracking.
• Performed end to end system testing and SIT (System Integration testing) for Invitrogen’s Sales Opportunity Management Implementation on Confidential -Siebel CRM 8.0.
• Project involved in active participation in requirements phase, design reviews, testing activities including unit testing, system testing, integration testing.
• Lead offshore team for functional testing and Performance Testing using Load Runner for weekly build testing and sanity testing and bug regression.

Environment: J2EE, Confidential -Siebel 8.0, Confidential Quality Center Test Director, Load Runner, Windows NT Client/Server, Sun Solaris and Win NT, ClearQuest,, MS-Office.

Confidential

Lead QA Analyst

Responsibilities:

• Involved in writing system and integration test cases and scenarios for SLA Escalation, ticket management, email notification and other business processes within ticketing application and Hotjobs Order management and provision application using Siebel 7.7
• Involved in Yahoo’s Call Center CRM implementation which included host of integrated interfaces built using SAP SD (Sales and Distribution) and Siebel enterprise solutions to manage yahoo’s organization, contact, account management, pre sales and distribution.
• Set up QA Team and Lead Offshore unit in Bangalore for Functional Automation testing using QTP and regression testing for all 3 Implementation projects simultaneously.
• Involved in testing Yahoo’s SAP based Sales and Distribution process that helps to optimize all the tasks and activities carried out in sales, delivery and billing.
• Involved in testing incentive compensation management module to test sales credit based on organization, department and sales hierarchy.
• Involved in gathering business requirements from various user groups and analyzed the requirements for testability and also design and map traceability matrix.
• Involved in creating QA test plan and QA performance test plan and strategy including performance test plans and UAT test plans.
• Executed system test scripts, integration scripts and regression test suites from test director and managed daily execution status report.
• Developed detailed performance strategy for end-to-end Siebel functionality and Yahoo sales interfaces and developed test scripts using load runner to simulate account, contact and opportunity management and quotes.
• Worked closely with business users of Yahoo Ops And business analyst to communicate issues, bugs, reports during test execution and discussed and designed business critical scenarios and test scripts. Also analyzed user requirements to design and develop UAT and System testing scripts and used design document and PRD’s and test script documents to crate a trace-ability matrix.

Environment: SAP, Siebel, Loadrunner with Siebel Web correlation, J2EE, Websphere, Bea Weblogic Application Server Confidential 9i, Windows NT Client/Server, Sun Solaris and Win NT, Test Director, ClearQuest, RequisitePro, MS-Office.

Confidential

Sr. Validation Analyst

Responsibilities:

• Involved in qualifying Confidential premiere application GeneMapper ID by verifying that the HID functionality met the requirements specified in requirements/specifications.Performed IQ and built sanity testing by installing/un-installing paths for GeneMapper ID 3.1 and demo versions for all supported scenarios and configurations, and all applicable documentation. Testing included reviewing all installed items and review documentation including Read Me files, tutorials, user guides, etc.
• Performed OQ validation on GMID applications several key functionalities, which included working with Bins, Stutters, Markers, Size standards, Analysis Methods, Plot settings, analyzing projects and printing functionality.
• Also involved in performing OQ for LIMS using eLab. Performed extensive end-to-end OQ validation on Project Management, Sample management, working with Reagents, Containers and Protocol Management and Methods. Also performed validation on Administration Management module to setup users, groups and their roles and responsibilities.
• Responsible for documenting test scripts, risk assessment document, test matrix and test summary reports and executed test cases, reviewed, verified test results, identified and reported issues and provided summary test reports.
• Worked closely with business users and business analyst to communicate issues, bugs, reports during test execution and discussed and designed business critical scenarios and test scripts for PQ.

Environment: J2EE, Windows NT Client/Server, Sun Solaris and Win NT, ClearQuest, RequisitePro, MS-Office.

Confidential

Sr. Validation Test Engineer

Responsibilities:

• Responsible for creating IQ and OQ Protocols, Combined Technical/ Risk Assessment and Test Summary Reports.
• Responsible for creating test scripts, executing test cases, reviewing and verifying test results, identifying and reporting issues and providing summary test reports.
• Assured that all validation documentation such as IQ's, PQ’s, process validation and software validation documents were in compliance with GxP regulations.
• Managed multiple projects at a time, which included Customer Order Entry solutions Confidential Application Automated Clinical Research System- Confidential Application, Shipping Manifest Interface, Plateaus Online GMP training application and several other M&E project closeouts.
• Developed Requirements Traceability Matrix (RTM) to track requirements during Testing
• Involved in reviewing Validation Plan, System Design Specifications, User and Functional Requirement Specifications, Unit and System Integration Testing, IQ/OQ/PQ Testing, Training, SOPs, Validation Summary Reports.

Environment: J2EE, Confidential 11i, Windows NT Client/Server, Sun Solaris and Win NT, MS-Office, SQL

Confidential

Computer Validation Analyst

Responsibilities:

• Involved in qualifying CMS Clinical Management System for their phase II clinical trials. CTMS Qualification included following modules (1) Clinical Program Management (2) Site Administration (3) Adverse Event and Complaint Reporting (4) CAPA Management (5) Regulatory Reporting.
• Assisted QA group for Siebel - SAP SD implementation of Service Request and Call Center module of companies Business critical process and its integration with Customer Order Entry interface.
• Involved in writing scripts for integration of SAP SD and Siebel Call Center applications which included creating sales order, creating delivery, billing and shipping, customer account and contact management and checking inbound and outbound transactions to ensure several transaction data are updated in each interfaces.
• Responsible for performing requirement analysis to define application testability matrices.
• Involved in designing, development and approval of Master Test Plan as per Bio-Tech Industry guidelines.
• Designed system use case document and used this as a guideline to write end-to-end functional test cases.
• Assisted business team to develop and execute User acceptance test cases.
• Developed functional test cases, which also included end-to-end life cycle workflow process of different types of users.
• Developed unit test cases to assist developers in unit and component testing.
• Involved in execution of system testing and Integration testing for 3 cycles incorporating change request into test cases.
• Used requirements manager component in Test Director to link all application requirements to test cases, test results and defects to ensure thorough test coverage.

Environment: Siebel 7.7 and 6.1, SAP SD, Confidential 9i, SAP, Windows NT Client/Server, Sun Solaris and Win NT, Test Director, ClearQuest, RequisitePro, MS-Office.

Confidential

Computer Validation Analyst

Responsibilities:

• Involved in Qualifying several Clinical Research Information System (CRIS) application projects that included, Clinical Research Inventory Management (CRIM), EDC-CDMS (Clinical Data Management System), CDC (Clinical Data Capture) and CTMS (Clinical Trial Management System).
• Responsible for requirement analysis, developing test plan and writing of test cases, scenarios and test scripts to cover all the requirements for all above-mentioned CRIS applications.
• Wrote Test scenarios and execute OQ for e-CRF (Electronic case reports and forms) for CDC application using ClinTrial Phase Forward application.
• Wrote test scenarios for Integrating Kofax scanning application for integrating CDC with CTMS to scan medical reports and documents to a standardized format and store/Update records on CTMS.
• Performed Integration test included Siebel eClinical interfaces integration to companies Sales and distribution in SAP for managing customers, managing orders, shipping transactions and billing.
• Involved in validation of LIMS Validation group using eLab. Performed extensive end-to-end OQ validation on Project Management, Sample Management, working with Reagents, Containers, Manage Protocols and Methods.
• Involved in IQ validation of eLab Database module eDBA and eLAB client installation and also involved in validation of Administration Management by setting up users, groups and their roles and responsibilities.
• Performed Requirement based functional and systems testing, integration testing of all qualifying applications, 21 CFR Part 11 regulatory testing, configuration testing, load testing, regression testing and unit testing.
• Wrote test cases and documented for Compliance/Validation and Regulatory issues.
• Created test cases & test plans using Test Director and executed test cases and test scripts using manual and automated mode in Test Director and generated several test execution reports.
• Developed Strategy for Performance Test and Setting up Test Environment.
• Created Load test scenarios, which emulate the real time usage model of the web application using LoadRunner Controller.
• Performed expert analysis for identifying the bottlenecks in web application architectures using LoadRunner analysis tool, Unix and NT monitors.
• Worked on day-to-day basis with Business Analyst to capture various requirements and business scenarios and capture every requirement into a test case and make sure Guidant’s regulatory requirements are validated.
• Prepared several useful matrices for defect management and suggested and implemented new strategy for reporting matrices on test case design and development use case and test case execution.

Environment: Siebel 7.7, SAP SD, Win Runner 6.5, Loadrunner 7.0, Java J2EE, servelet, Websphere, Test Director 6.5.Win NT, WebLogic, SQL, Confidential, Load Runner, RequisitePro, MS-Office.

Confidential

Application QA Analyst

Responsibilities:

• Leading and directing a QA team of 20 test engineers, both onsite and Cisco offshore (India) facility
• Developed Test strategy and test planning for a sales finance CRM application based on Siebel Incentive compensation for the various sales hierarchies.
• Designed test strategy for both for standalone siebel apps as well as integration with the legacy system
• Performed System testing, Integration testing, Interface testing for siebel’s incentive compensation module
• Analysis of various Siebel E-Sales applications with respect to requirements and actual deliverables.
• Performed gap analysis between current systems and siebel implementation.
• Conducted Business Acceptance testing (BAT) with various program managers and real time users for respective applications.

Environment: Siebel 7.5 (Sales Module) Confidential -UNIX, SUN-Solaris, and Win NT, Load Runner, Win Runner 7.0, Test Director 7.2, MS-Office.