Address
Form of work Roles & Responsibilities:
- Perform review for GxP and non-GxP systems to ensure compliance with regulatory requirements
- Experience on decommission and data integrity (ALOCA+)
- Experience in supporting Data Migrations from validation perspective
- Working knowledge on end-to-end validation of GxP applications
- Adept with Agile and Waterfall methodology-based software development and has prior experience in Computer System Validation using Agile methodology
- Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability
- Ensures Risk Assessment is completed for all the requirements and test cases are designed In reference to the risk levels identified for the requirements
- Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement
- Ensures pre-executed test protocol has the necessary test data requirements to run the tests
- Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process
- Able to author Validation Plan and compile Validation Summary Report and generates RTM
- Performs Change Requests Implement and Close Change Request which includes to check for the application controls and associated documentation process for end to end Change Request process
