Perform System Assessment, Data Integrity Assessment, Third-party Risk Assessments.
Change Record Management in CCMS and ServiceNow.
Work with Test Leads to ensure test coverage for all requirements.
Review Test Cases to ensure test cases design and Execution are performed as per Good Practices(GP) guidelines.
Support UAT test cases design and execution.
Work with System Owner(SO) to get all IQ and OQ scripts approved in ALM.
All Validation documents are reviewed and approved.
The ability to plan, organize, and execute complex validation projects within timelines and budget constraints is essential.
Required Skills/Qualifications
Minimum Years of Experience 10+ years.
A strong understanding of computer systems, software development, and validation methodologies is crucial.
Traceability, IQ and OQ protocols, System SOP.
Experience in ensuring the quality and compliance of computer systems in regulated industries like pharmaceuticals, medical devices, or healthcare is highly desirable.