SUMMARY

• Over 7 years of experience in Validation/QA/QC and testing of process and applications in Pharmaceutical Industry.
• Good experience in using Risk Based approach to validate Category 3, 4 tools and custom developed systems.
• Excellent experience in validating wide variety of applications and infrastructure - Business Intelligence Reports, Argus Safety, SAP, Excel spreadsheets, Electronic Document Management System (Documentum), Track Wise, LIMS, and ArisG,
• Good expertise in developing the following validation deliverables – Risk Assessments, Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ test scripts, Deviation/Incident Reports, Change Controls and Problem Reports.
• Expert in using Quality Center for managing tests and defects.
• Experience in providing training to business users on Good Documentation and Test Execution Practices.
• Developed functionality Test Scripts to test the system functionality based on approved system requirements.
• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC).
• Involved in Change Control and developed Change Notification Form (CNF).
• Thorough knowledge of system integration for process automation with compliance to CFR Title 21 Part 11 of the FDA regulations.
• Extensive experience in performing 21 CFR Part 11 Gap Analysis, Risk Analysis and developing Remediation Plans.
• Develop Test Plan, Test case Specification and Test Release Reports for all phases of testing i.e. unit testing, Integration testing IQ, OQ, PQ and UAT Testing.
• Strong hands on experience in using Test Director, Win Runner and Load Runner.
• Performed various boundary tests as well as data validation to ensure record retrieval and search engine tests.
• Experience in executing software validation protocols (installation and operational qualifications.)
• Excellent knowledge of 21 CFR Part 11, GLP, cGMP and GAMP guidelines.
• Demonstrated capabilities to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.

PROFESSIONAL EXPERIENCE

Confidential, IL

Sr. Validation Analyst

Apps: Trackwise, IRMS

• Involved in the Global Implementation and Validation of CAPA, CCM Workflows and IRMS application.
• Reviewed and updated end to end validation documentation for IRMS, Track wise (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 Track wise and IRMS
• Drafted IQ test cases for verifying configuration of Track wise 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 Track wise 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 Quality Center.
• 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 Track wise.
• 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.
• 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.

Confidential, MA

Validation Analyst

Apps: Documentum, Trackwise

• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification.
• Performed Computer System Validation Assessment for Trackwise system to identify the validation deliverables for the project implementation
• Regarding documentum
• Involved in creation of Master Test Plan to strategize the test approach in various test cycles.
• Developed IQ/OQ/PQ Scripts.
• Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
• Involved in the documentation for protocols, Operation Qualification (OQ) and Performance Qualification (PQ).
• Managed and organized requirement coverage, Test Case Management and Defect Management using and communicating between Team Lead, Developers to resolve the technical issues.
• Conducted Installation Qualification and documented the test results, deviations and corrective actions.
• Conducted Functionality testing and Interface testing during the Operational Qualification.
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Involved in executing test scripts and documented test results in Test Summary Report.
• Created Traceability Matrix to keep track of all the requirements and test scripts.

Apps: Track Wise, Argus Safety Systems

• As necessary, updated the User Requirements Specification (URS) and Functional Requirement Specifications (FRS)
• Involved in creation of Qualification Protocols to strategize the test approach in Validation and Production environments.
• Developed IQ/OQ/PQ Scripts for Track Wise and Argus using HP Quality Center.
• Code Reviewed Java, PL/SQL and SQL components.
• Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
• Involved in the documentation for protocols, Operation Qualification (OQ) and Performance Qualification (PQ).
• Managed and organized requirement coverage, Test Case Management and Defect Management using Quality Center.
• Conducted Installation Qualification and documented the test results, deviations and corrective actions.
• Conducted Functionality testing and Interface testing during the Operational Qualification.
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Involved in executing test scripts and documented test results in Test Summary Report.
• Created Traceability Matrix to keep track of all the requirements and test scripts.

Apps: SAP R/3, DOCUMENTUM

• Developed Master Test Plan to strategize the testing approach to test SAP R/3 modules to meet the requirements defined in FRS.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the SAP test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Prepared test data for Positive and Negative testing.
• Developed test plans and test cases for Functional and Regression Testing
• Involved in executing the test scripts of SD, MM, PP, WM, IM modules of the SAP implementation.
• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.
• Involved in executing the test scripts to test the interface between SAP and LIMS system (QM-IDI interface).
• Involved in validating various SAP smart forms, reports and ALVs developed using ABAP/4 language.
• Executed and reviewed the test scripts for new SAP transactions, Customized transactions, tables.
• Developed the Test Scripts to generate the Audit Trail reports to verify the creation, modifications to the records are captured in audit trail table logs.

Apps: Lab ware LIMS, Track Wise

• Prepared documentation for all aspects of the Computer Systems Validation (CSV) lifecycle, in accordance with FDA regulations including 21 CFR Part 11.
• Involved in developing Test Plans and Summary reports for the Track Wise system implementation.
• Performed Computer System Validation Assessment for Lab ware LIMS system to identify the validation deliverables for the project implementation.
• Analyzed System Requirements to document in Function Requirements Specification (FRS) and Design Specifications (DS).
• Developed Master Test Plan for LIMS implementation and it’s interface to SAP R/3 via Web Methods, to define the test strategy and test cycles.
• Developed Application Installation Qualification (IQ) to install the application and Functional Test Protocol (OQ) as part of testing.
• Tracked all deviations and corrective actions as part of test process.
• Implemented Good Documentation Practices (GDP) to review and approve the Test Scripts pre execution as well as post approval.
• Developed Test Summary Report to summarize all test activities done in controlled test environment.
• Conducted Risk Analysis meetings to analyze the risk involved in implementing the Track Wise system in the existing business process.
• Prepared Traceability Matrix to define the relationship between requirements, design specifications and test scripts.
• Developed the Final Validation Summary Report and Go-Live memo to issue the LIMS system into production use.