Test Cases Management

Summary

*+ years of experience in Information Technology with emphasis in Verification, Validation, 21 CFR Part 11 and 21 CFR part 820 and Quality Assurance.

Experience in developing and analyzing Test Plans and Test Scripts to check the functionalities of the application for 21CFR part 11 and 21 CFR Part 820 compliance

Expertise in technical writing of Validation Protocol, performing Gap Analysis and developing Remediation Plans.

Experience in conducting Manual Testing and Automated Testing.

Experience in validation of Laboratory Information Management System (LIMS)

Experience with managing records using Oracle database using SQL.

Expertise in all aspects of the Computer Systems Validation Lifecycle for compliance with FDA Regulations.

Expertise in Technical Writing of Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Validation Master Plan (VMP) and SOPs.

Expertise in writing Test Plans, Test Scripts and Test Summaries.

Experience in performing Gap Analysis for FDA compliance and developing Remediation Plans.

Experience in Validation Practices in GAMP, cGMP, cGLP, and cGCP.

Experience in Electronic Document Management System using Documentum 5i and Workspace.

Maintained the Test Matrix and Requirement Traceability Matrix.

Experience in full Software Development Life Cycle using the Waterfall Model and Rational Unified Process (RUP).

Expertise in various types of testing like Black Box testing, White Box testing, Load testing, Stress testing, Performance testing, Security testing, Front end testing, Back End Testing, Security testing, Positive testing, Negative testing, Sanity testing and System testing.

Experience in implementation, migration, custom development, and validation of Laboratory Information Management System (LIMS) using SQL*LIMS.

Highly motivated with excellent analytical, interpersonal, verbal and written skills.

Technical Skills

Life Sciences

FDA Compliance, 21 CFR Part 11, IQ, OQ, PQ, RTM, cGxP, LIMS.

Testing Tools

Win Runner, Load Runner, Rational Suite, HP Quality Center

OS

Windows NT, Windows 9x/ME/XP/2000, UNIX and Linux

Databases

Oracle 8i, MySQL, MS Access, SQL Server

Internet Servers

Apache, Tomcat and WebSphere.

SDLC

Waterfall, RUP.

Applications

MS Word, Excel, MS FrontPage, Dreamweaver, SQL*LIMS, Documentum.

Work Experience:

Stryker, Mahwah, NJ Dec 2013 -Till Date

Role: Validation Analyst

Applications: Labware LIMS / Trackwise lead

Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

The project is Retrospective validation of Laboratory Information Management System (LIMS). LIMS is a Laboratory Information Management System where all sample data is stored, managed, queried and analyzed.

Responsibilities:

Prepared Validation Master Plan (VMP) for validating LIMS.

Assisted in documentation and development of SOPs for Trackwise.

Responsible for analyzing and reviewing validation deliverables like User Requirement specification and Functional requirement Specification.

Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.

Developed OQ and PQ test cases for Trackwise.

Drafted IQ test cases for verifying configuration of Trackwise workflows.

Developed and reviewed test scripts and test cases for 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.

Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11.

Involved in good documentation practice in different stages of validation life cycle in compliance with 21 CFR Part 11 and 21 CFR Part 820.

Performed execution of User Acceptance Test for LIMS.

Developed test scenarios for testing workflow paths in Trackwise.

Conducted GAP analysis and prepared Remediation Plan.

Performed change control by assessing proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.

Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Environment:MS Word, Trackwise,,21 CFR Part 11, MS Project plan, Crystal reports, Trackwise, Agile, Oracle SQL Developer, MS Excel, Apache Web server, Linux, XML

TAKEDA PHARMACEUTICALS, IL Jan 2013 – Nov 2013

Validation Analyst

Apps: Trackwise, IRMS

The wholly owned subsidiary of Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A.,Inc. (TPUSA) is among the top 15 pharmaceutical companies in the United States. TPUSA was founded in 1998 to accelerate Takeda's global expansion into the U.S. market. Takeda Development Center Americas, Inc. has a robust pipeline of compounds in multiple therapeutic areas including metabolic and cardiovascular diseases, central nervous system, respiratory and immunology, oncology and general medicine.

This project involved validating computer software application and analytical laboratory equipment in compliance with regulations and validating the operating procedures. Computer System validation of IBM SCORE (Solution for Compliance in a Regulated Environment), which is an Enterprise Document Management System (EDMS) and Track Wise v 8.0 Quality Management System (QMS).

Responsibilities:

Involved in the implementation and Validation of Global IT applications, CAPA, CCM Workflows and IRMS.

Reviewed and updated end to end validation documentation for IRMS, Trackwise (CAPA, CCM) to ensure compliance with company policies and procedures.

Hands on review of the following deliverables– Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.

Developed OQ and PQ test cases for Trackwise and IRMS

Drafted IQ test cases for verifying configuration of Trackwise workflows.

Reviewed and tested IBM Cognos reporting functionality for IRMS6.0.

Communicated and worked with PV group and developed suitable requirements as per URS specifications.

Developed Performance Qualification for Citrix based tool MIRS – IRMS

Coordinated the execution of Operational Qualifications Test Scripts with different modules and specifications.

Assisted in documentation and development of SOPs for Trackwise and IRMS 6.0 application.

Conducted Regression testing and run the scripts in validated environment for performance of the application.

Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in (ALM).

Developed Detailed Risk Assessment documentation for managing the risk levels used before validation the system.

Developed Trace Matrix document for mapping the URS, FS, DS (Design Specification), IQ, OQ and

Developed test scenarios for testing workflow paths in Trackwise.

Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.

Conducted reporting and tracking of defects using Quality Center.

Developed and maintained Traceability Matrix documents of all systems.

Implemented cGxP’s (GMP, GLP, GCP) and GAMP5 guidelines in the systems.

Involved in the development of the Information Protection and Risk Management assessment

Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.

Environment: Trackwise 8.0,SQL, GMP, GLP, GCP, DB2, SAS database Windows 7, MS Excel, Word.

Brio Pharma Technologies, Aug 2009 – Dec 2012

Hyderabad, India

Validation Consultant

The project involved remediation of lab instruments and bringing them into compliance with FDA regulations. It also involved in the integration of the instruments system with the Calibration Manager System.

Responsibilities:

Involved in Validation of Lab Instruments (FTIR & HPLC Shimadzu Series)

Involved with Risk Analysis and prepared and reviewed remediation Procedures, Test cases & Validation Summary Reports

Analyzed as is functional specifications and requirements to categorize the units.

Developed SOPs, System Admin and Instrument Operating Procedures.

Developed Protocols IQ, OQ and PQ.

Involved in good manufacturing practice in different stages of validation life cycle in compliance with 21 CFR Part 820.

Involved in the design and implementation of data collection, analysis and validation using MS-Access and MS Excel.

Developed User Acceptance Protocol to describe the specific objectives, procedures, data sets, test scenarios, expected results, and acceptance criteria for the PQ/ UAT process

Worked on EQ procedures, work instructions and templates.

Used authority checks to ensure that authorized individuals can enter, sign or change data

Involved in writing protocols for stress testing and performance testing

Involved in the execution of Test Protocols (IQ, OQ and PQ),

Participated in all Project Meeting and involved resolution of various issues

Environment:

Validation Testing, IQ,OQ,PQ, UAT Testing, Performance Testing, MS Excel, Word, Case wise Corporate Modeler, Process Modeling,

Education:

Bachelor of Engineering in Electronics and Communication, 2009

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