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Validation Analyst Resume Example

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VALIDATION ANALYST
  • https://github.com/Sugeeta32
  • https://sugeeta32.github.io/Sugeeta-portfolio/
Professional Summary

Validation analyst with over five years of experience in Validation and testing. Thorough understanding of the principles of Computer Systems Validation, SDLC & STLC methodologies. Excellent understanding of key Pharmaceutical compliance regulations like 21 CFR part 11, GxP, GAMP 5, Data security and, Data Integrity. Talented in areas such as Quality Management, Document Management and Change Management. Worked in developing and managing GxP system lifecycle documentation. Proven experience validating Documentum and Veeva the Electronic Document Management Systems using Micro Focus ALM and ALM Vera. Strong background in both manual and automation testing. Excellent team player and ability to work independently.

Skills
  • HP ALM Quality Center, VERA, Jira
  • 21 CFR Part 11, GAMP
  • Document management - Documentum and Veeva Vault
  • Trackwise CAPA
  • VBScript, SQL, Unix, Shell Scripting
  • Oracle, SQL, SQL Server
  • MS-Word, MS Excel, MS Outlook, MS Access
  • Test Automation tool - Selenium, Cypress
  • Verbal and written communication
Work History
Validation AnalystCompany Name - City, State03/2020 - Current
  • Participated in requirement gathering and analysis meeting to understand the requirements to create detailed manual test cases for implementing document management system Documentum and Veeva Vault Quality Docs.
  • Validated templates and results workflow for Veeva Vault Quality Docs.
  • Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
  • Responsible for assisting in the implementation of software systems in compliance with regulatory requirements as they pertain to 21 CFR Part 11, Data Integrity and GAMP 5 standards.
  • Authored and reviewed CSV deliverables (Validation Plan, URS, RTM, IQ, OQ, PQ/UAT, Computer System Risk Assessment, and Validation Summary Report).
  • Support Quality System development and improvement with respect to GMP systems and development team compliance to FDA regulations.
  • Used HP ALM to create and execute test cases and Defect Management.
  • Pre and post execution approval for test sets, failing a run and creating defect, modify a test step and approving record using Approval Routes, Signatures, and Test Execution Report with MicroFocus ALM VERA.
  • Responsible for Initiation of Deviation/Investigation in Trackwise CAPA system.
  • Performed additional tasks as required by the Team & Management
  • Environment: Veeva Vault, Documentum, HP QC/ALM, MicroFocus ALM VERA, Jira, and Trackwise.
Automation DeveloperCompany Name - City, State08/2019 - 03/2020
  • Collaborated on all stages of systems development lifecycle, from requirement gathering to application deployment in Heroku.
  • Performed software testing to uncover bugs and troubleshoot issues prior to application launch.
  • Wrote and optimized test cases to maximize success of manual software testing with consistent, thorough approaches.
  • Created accurate and efficient test scripts in Selenium and Cypress to manage automated testing of application features.
Test AnalystCompany Name - City, State04/2015 - 08/2019
  • The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T cell platform enables the engineering of T-cells to target and destroy cancer, including solid tumors.
  • Participated in a requirement gathering and analysis meeting to understand the requirements to create detailed manual test cases for implementing document management system Documentum, CAPA system (Trackwise).
  • Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
  • Responsible for assisting in the implementation of software systems in compliance with regulatory requirements as they pertain to 21 CFR Part 11, Data Integrity and GAMP 5 standards.
  • Authored, reviewed and approved CSV deliverables (Validation Plan, URS, RTM, IQ, OQ, PQ/UAT, Computer System Risk Assessment, and Validation Summary Report).
  • Support Quality System development and improvement with respect to GMP systems and development team compliance to FDA regulations.
  • Responsible for testing end to end workflows of all the applications as per the business requirements and to maintain data validity and data integrity.
  • Used HP ALM to create and execute test cases and Defect Management.
  • Responsible for Initiation and Managing Deviation using CAPA System.
  • Performed additional tasks as required by the Team & Management Environment: Documentum, HP QC/ALM, MicroFocus ALM VERA, Jira, and Trackwise.
Education
Quality Assurance And Coding Rutgers University - City03/2020
Master: Business ManagementMAISM - City
Bachelor: Liberal Arts And SciencesIGNOU - City
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Resume Overview

School Attended

  • Rutgers University
  • MAISM
  • IGNOU

Job Titles Held:

  • Validation Analyst
  • Automation Developer
  • Test Analyst

Degrees

  • Quality Assurance And Coding
    Master : Business Management
    Bachelor : Liberal Arts And Sciences

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