Job Description :
Analyze User Requirements and Functional Specification for the Project and Identify Testing Scope Based on Testing Scope, Create an Estimate of Testing Activities and Create a Testing Schedule
Come up with a Testing Approach and Strategy for the Project and Create Test Plan per CSL BT QMS process
Coordinate with Project Team including Business to Identify Key Functional Test Scenarios and UAT Test Scenarios
Create Test Scripts, upload in QC Vera HP ALM System, Review with Validation Team

Must Have Skills:
Strong understanding of 21 CFR part 11, GAMP and standard
Good Documentation Practices (GDP) for GxP projects
Experience with HP ALM & GxP Validation Workflows
Experience with System Functional Testing, Integrations Testing, Data Migration Testing and UAT Coordination
Experience in Test Script Creation and Testing in a Validated Environment
Experience as a Tester or Test Lead in Field of Clinical Trials Management or other Clinical Systems within R&D