Vijaya Thati

Email: jnpedv@r.postjobfree.com

Phone: 508-***-****

SUMMARY

• Over 6 years of experience in IT sector, specializing in the area of Validation of Pharmaceutical applications, Software Quality Assurance testing, configuring various Laboratory Information Management Systems.

• Specific expertise in developing validation documents in accordance with SDLC and company SOPs.

• Complete understanding of System Development Life Cycle involving various phases like Requirements, Analysis/Design, Development, Testing, Implementation, and Retirement.

• Developed validation documents for Documentum, LabWare LIMS and STARLiMS. Empower2 and applications in accordance with 21 CFR Part 11 & GxP regulations.

• Gathered requirements from business users and documented in User Requirement Specification Documents.

• Prepared/Executed Installation Qualifications, Operational Qualifications, and Performance Qualifications for Documentum, Labware LIMS, STARLiMS, Empower2.

• Prepared Master Test Plan, Test Scripts and Test Summary Report for all cycles of testing in the project implementation.

• Participated in reviewing User Requirement Specification document (URS), and System Requirement Specification (SRS) and Design Specification (DS) for software applications.

• Worked as a user to perform Performance Qualification/User Acceptance testing (PQ/UAT) for various applications.

• Involved in making Documentum systems Part 11 compliant by verifying Operational Checks, System security and Authority checks.

• Wrote and Revised Standard Operating Procedures (SOP s) for validation of computer systems.

• Experienced in validating LIMS, CDS and qualifying IT infrastructures to be compliant to GxP's including 21CFR part 11 across those GxP's.

• Prepared Requirement Traceability Matrix (RTM) to keep track of requirements and the test scripts for various applications.

• Reviewed the test scripts in accordance with cGMP regulations to assure that the system was developed according to the requirements.

• Prepared Security Installation Checklists and Server Installation Qualifications for hardware servers.

SKILLS

Laboratory Management Systems LabWare, STARLiMS

Chromatographic data Systems Empower2

Spectroscopic systems UVProbe, IRSolutions

Programming Languages C, C++, Java, SQL, PL\SQL,.Net and VGL

Web Programming XML, JSP, HTML, JavaScript and Web services

Operating Systems Windows, Solaris

Databases and Reporting tools Oracle, SQL Server, MS Access and Crystal reports XI

Testing tools Quick Test Pro 8.2, Mercury Quality Center

Content Management Systems Documentum

GENZYME, Framingham, MA Jul’10- May’12

Sr. Validation Consultant

Responsibilities

• Involved in developing Operational Qualification Test Protocol for STARLiMS.

• Validated various modules in STARLiMS according to Part 11 and GxP regulations as part of project implementation.

• Involved in preparing Test Scripts for STARLiMS project implementation.

• Prepared OQ Test Scripts based on Functional Requirement Specifications in compliance with Master Test Plan and Validation Plan.

• Developed OQ scripts to test the STARLiMS functionality including, but not limited to Sample Group Templates, Batch Manager, Result Entry by Sample, Result Entry by Run, Specification management, Users, Roles, Sites, Inventory Management, Equipment Management, Stability, etc..

• Developed OQ test scripts to test the custom functionality of the system.

• Developed OQ test scripts to test the custom reports.

• Involved in preparing PQ scripts based on User Requirement Specifications to test the integrated functionality of the LIMS system.

• Prepared OQ Test Scripts to validate various reports.

Elan, King of Prussia, PA May’09- Jun’10

Sr. Validation Analyst

Responsibilities

• Involved in developing Operational Qualification Test Protocol for Labware LIMS.

• Validated various modules in Labware LIMS according to Part 11 and GxP regulations as part of project implementation.

• Involved in preparing Test Scripts for Labware LIMS project implementation.

• Prepared OQ Test Scripts based on Functional Requirement Specifications in compliance with Master Test Plan and Validation Plan.

• Developed OQ scripts to test the Labware LIMS functionality including, but not limited to Login Template, result entry, Stability, Products, Sample Labels, custom reports, Labware LIMS etc.

• Developed OQ test scripts to test the custom functionality of the system.

• Developed OQ test scripts to test the custom reports.

• Involved in preparing PQ scripts based on User Requirement Specifications to test the integrated functionality of the LIMS system.

• Prepared OQ Test Scripts to validate various reports.

Schering - Plough, Memphis, TN Mar’08- Apr’09

Validation Analyst

Responsibilities

• Involved in developing Operational Qualification Test Protocol for Empower2 Chromatographic system.

• Validated various modules in Empower2 Chromatographic system according to Part 11 and GxP regulations as part of project implementation.

• Involved in preparing Test Scripts for Empower2 Chromatographic system project implementation.

• Prepared OQ Test Scripts based on Functional Requirement Specifications in compliance with Master Test Plan and Validation Plan.

• Developed OQ scripts to test the Empower2 Chromatographic system functionality including, but not limited to Data Acquisition from Agilent 1100/1200 HPLC and 6890 GC, Method management, creating and managing Empower nodes and Chromatographic systems etc.

• Developed OQ test scripts to test the core functionality of the system.

• Involved in preparing User Manual based on Use log.

• Executed Operational Qualification Test Scripts and documented according to Test Plan.

• Prepared Deviation Reports for Configuration and Non-Configuration changes in Test Script execution in system Validation environment.

• Documented all phases of system life cycle as required by FDA regulation under 21 CFR Part 11(Electronic Records and Electronic Signatures) to successfully complete QA checkpoints.

• Prepared and updated Requirement Traceability Matrix (RTM) to keep track of requirements and the test scripts.

• Good working knowledge of Empower2 Chromatographic system and Agilent instruments (1100, 1200 and 6890).

• Prepared OQ Test Scripts to validate various reports..

AstraZeneca, Wilmington, DE Nov’07 – Feb’08

Validation Analyst

Responsibilities

• Involved in developing Operational Qualification Test Protocol for Documentum v5.3 implementation.

• Validated various modules in Documentum v5.3 according to Part 11 and GxP regulations as part of project implementation.

• Involved in preparing Test Scripts for Documentum v5.3 project implementation.

• Developed Test Strategy to describe the test procedure, test strategy for the Documentum v5.3 implementation.

• Prepared OQ Test Scripts based on Functional Requirement Specifications in compliance with Master Test Plan and Validation Plan.

• Worked closely with technical team to resolve the configuration deviations.

• Developed OQ scripts to test the Documentum v5.3 functionality including, but not limited to eRoom, WebTop, Security Management (Access Control List or Permission Sets), Workflows, Group Management, User Management, Role Management, Document Management (Check-in, Check-out, Check-in override, Document archival and retrieval), Version Control,.

• Developed OQ test scripts to test the core and customized functionality of the system.

• Executed Operational Qualification Test Scripts and documented according to Test Plan.

• Prepared Deviation Reports for Configuration and Non-Configuration changes in Test Script execution in system Validation environment.

• Involved in Change Control process for system configuration changes while OQ execution.

• Documented all phases of system life cycle as required by FDA regulation under 21 CFR Part 11(Electronic Records and Electronic Signatures) to successfully complete QA checkpoints.

• Wrote Test Summary Reports.

• Good hands-on experience of Documentum v5.3.

Bear Stearns, NY, NY

Oct’06 – Oct’07

QA Analyst

Responsibilities

• Developed functional test cases for manual testing and created automatic testing scenarios using mercury quality center

• Involved in Manual testing of the application

• Modified and developed the test cases for Automation testing and created Automation test scripts using Quick test pro 8.2

• Used SQL scripts to verify the Integrity of the data and to perform database testing

• Mercury quality center is used to store the test plan, test cases and to report bugs.

• Involved in Session level and Application level testing of FIX 4.2 Protocol

• Created different scenarios for automation like creating client baskets, creating trading baskets, moving orders from client basket to trading basket, creating orders, executing the orders,

• Tested different features of Waves like Cancel Requests, Cancel/Replace Requests and sending orders to the different destinations like AMEX, NASADAQ and OTC.

• Tested the various scenarios for GMO and static data

• Wrote test cases for positive and negative scenarios for functional, GUI and security testing.

• Executed test cases manually to verify the actual results against expected results.

• Automated test cases for regression testing using Win Runner automation tool.

• Tested for Baseline, Load, Stress, Soak, Peak and Scalability.

• Used TOAD for SQL Query from Oracle database.

SIGNA INDUSTRIES LIMITED,INDIA May’05 – Mar’06

QA CONSULTANT

Responsibilities

• Involved in Analysis, Design, Coding and Testing.

• Determined and developed test cases.

• Tested all the screens manually for their contents and functionality.

• Did Unit testing and Integration testing for the application.

• Conducted Database testing using SQL.

• Tested the application for Configuration stability.

• Participated in meetings to discuss application issues and like scenarios.

• Reported and documented identified defects.

• Designed database tables, user interface screen templates, report templates.

• Developed user interface screens for new customer, nominee, bank details, and type of fixed deposit.

• Developed the events to validate user inputs such as depositor age, amount, and deposit period.

• Developed events to calculate deposit maturity date, maturity amount, interest, premature withdrawals amount and interest.

• Developed reports such as Premature Withdrawals, Matured but not Claimed Deposits, Depositors Information, Carry Forward Deposits.

EDUCATION

• Masters in Computer Applications (M.C.A)

Contact this candidate