Job descriptionDemonstrate attention to detail and accountability.Be responsible for assuring a system / application meets its requirements as outlined in system specification per the process defined in the Validation Plan for the project.Identify and escalate, as necessary, project risks and issues to the Validation Lead and Project Manager.Be able to prepare reports on defects and problems that arise during system testing.Have solid oral and written communication skills and teamwork skills.Be a good team player, able to meet deadlines, and handle changing priorities.Have strong judgment capabilities to clarify requirements when necessary.Have the ability to work with IT management, business analysts, and technical staff.Have solid experience working with validated systemsWork with business representatives to ensure the test cases reflect business rules and processes.As necessary, modify / create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity.Revise test cases as necessary, based on project team feedback.Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.Other duties include : run validation test scripts as assigned, assist with preparing and updating validation documentation, including specifications, defects, etc.