VALIDATION TESTINGCOMPLIANCE (REGULATORY)

Overall experience of 10 years with specialized in Testing and Validation of eTMS and eQMS system development and implementation. Min. of 6+ years of experience in eTMF (Trial Master Files), eQMS / eDQMS (Quality Management System) is mandatory Min. of 6+ years of experience in Validation, Clinical Trial experience, MF ALM is mandatory Min. of 6+ Testing and Validation of eTMS and eQMS system development and implementation is mandatory. Testing Activity Details 1. Test Strategy, Planning and Management a. Create test strategy and plan. Update document based on dynamics of the project. b. Identify and manage risk from testing perspective c. Engage early and proactively with project team to find defects early in the lifecycle d. Identify and provide technical recommendation to improve quality of the build e. Coordinate with offshore team members for timely progress of testing related activities f. Review testing deliverables created by offshore team members to ensure accuracy and validity in-line with test strategy, plan and overall program requirements. g. Plan and oversee data testing automation using tool provided by Exelixis h. Identify continuous improvement opportunities and review with Exelixis for implementation 2. Test Preparation a. Create detailed test cases for all scenarios (drafted so far and to be drafted) b. Create Scenarios and test cases for Data Quality checks in-pipeline c. Create Negative testing scenarios d. Create Query repository and map to test case for execution e. Test Data planning and preparation f. Test Environment planning and coordination to ensure availability on-time. g. Create test execution plan h. Coordinate with project team members for progress, review and updates 3. Test Execution a. Execute test cases, report defects, re-test defects, oversee execution by offshore team members b. Coordinate for clarifications, defect resolution c. UAT coordination and support d. Conduct daily testing stand-ups e. Send Daily Status report f. Coordinate with project team members for progress, review and updates Email :