Entry Level to Senior Level Validation Analysts (Multiple Positions):
Develop, review, and implement IQ/OQ/PQ validation protocols/reports and associated technical summary reports. Develop and Maintain Requirement Traceability Matrix (RTM) to cross-reference the functionality to the required test cases and scripts. Designed validation documents like validation plan, IQ/OQ/PQ protocols, test cases and traceability matrix, summary reports. Perform deviation investigations, deviation notifications, change control, capa, noes using process compliance. Validating the test plans, test cases and test protocols of validation master plan (VMP), execute test suites in accordance with the regressions software testing and complex end to end scenarios. Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for software analysis. Working on lab applications deployment, customization, configuration, installation, custom field development, report development, instrument configuration, support and validation of the entire system. Working on lims, track wise, empower, compliance wire(LMS), secure desktop, and lab systems related to drug development and preclinical studies. Working on biomerieux application which is sars-cov-2 r-genetest used in analyzing the data from the instrument in identifying the growth of microorganisms. Perform feasibility studies and may require traveling for setting up various systems across the nation.