Melina Bhattarai Mishra

• Developed test cases based on functional specifications and executed test scripts to ensure the system release functions as expected. • Worked closely with the Validation Lead and Business Analyst to ensure test scripts are ready for Operational Qualification (OQ). • Run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc. • Developed operational based test scripts from functional specifications. • Experience in Track wise for Complaint Management system (CMS). • Worked with business representatives to ensure the test cases reflect business rules and processes. • Revised test cases as necessary based on project team feedback. • Executed Test procedures in HP ALM (Application Lifecycle Management) for QA testing and assisted in Performance Qualification (PQ) testing. • Reported and executed the defects of the testing. • Developed and analysed test plans, test scripts/test cases to check functionalities of application of 21 CFR Part 11 compliance and FDA regulations.

• Reviewed User Requirements specifications, Functional Requirements specifications document. • Responsible for writing and executing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols to check successful operation of the application. • Participated in Risk analysis. • Created and maintained the Requirement Traceability Matrix (RTM) for the application. • Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements. • Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP). • Involved in writing and executing test cases and test scripts to validate certain functionalities of LIMS • Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP and GMP) FDA Assessment. • Ensure ongoing compliance with quality management system and maintain a high ethical standard and enforce data integrity. • Executed Test procedures in HP ALM (Application Lifecycle Management) and assisted in Validation testing using Unix/Linux environment

• Assisted in gathering and finalizing Business Requirements and Functional Requirements for the project. • Executed validation test scripts and documented test results in accordance with standards. • Facilitated the implementation of the software to meet the requirements of 21 CFR Part 11. • Maintained Requirement Traceability Matrix (RTM) for the application. • Developed and analyzed test plans, test scripts/test cases and Test Summary Report to check functionalities of application of 21 CFR Part 11 compliance and FDA regulations, GAMP 5, cGXPs (cGMP, cGLP, cGDP). • Authored and reviewed Requirement Traceability Matrix (RTM) and validation summary report. • Involved in generating CSV deliverables for modules of LIMS system. • Authored test protocols and reports for Installation Qualification (IQ), Operational Qualification (OQ), and Process and Performance Qualification (PQ). • Participated as a tester and Performed UAT against all requirements stated in the URS ensuring the Requirements are met satisfactorily. • Prepared the Disaster Recovery plan along with other validation deliverables. • Routed and Facilitated the OQ/PQ protocol for Pre-Approval and Post- Execution. Provided Clarifications on the Observations made, and technical Issues escalated, Objective evidence or Step by step Screenshots as and when required by Approvers and Stakeholders.