Sreya Sinha

Software Test Engineer @Pps

Understand the design and implementation of the functional components Identify, document, and investigate defects Prepare validation and verification plans Ensure releases have adequate tests, based on test plans Ensure the recording and reporting of test results Assess software functionality and usability Determine risk analysis and validation requirements Develop, implement, and monitor validation metrics Supporting validation program, change management and revalidation requirements Partner with Regulatory stakeholders to ensure compliance posture within the team Ensure regulatory compliance in validation processes with FDA 21 CFR Part 11, QSR and ISO 13485 regulatory requirements Ensure that team keeps validation and testing metrics including key performance indicators Train users on new component versions Ensure the development and maintenance of regression test suites Ensure the team has a well understood “definition of done” for the sprint backlog Partner with Scrum Master to drive continuous improvement within the Agile team Conduct API testing for various web application controls