Role : Validation Test Lead
Location : New Brunswick, NJ 08933(Hybrid- 2 / 3 Days per week from office)
Contract
Job Description :
- Should have experience on authoring GxP computer validation and Part 11 related documentation - compliance analysis, Compliance Plan, CSV risk assessment, USR, FRS and User Stories, Global change controls as per GxP standards
- Should have experience on documenting & reviewing Technical Design Specification documents
- Should have experience on developing, and executing test protocols (System & User Acceptance)
- Should have experience on documenting & reviewing System, User Acceptance & Data Migration Test scripts
- Should have experience on drafting and reviewing Data Migration Protocol & Data Migration report
- Should have experience on creation and execution of IQ, OQ scripts
- Should have experience on creating Test Summary Reports (system, user acceptance data migration)
- Should have experience in creating Requirements Traceability Matrix
- Should have experience in Decommission process, Developing Retirement Plan, Retirement Reports
- Should be able to provide validation estimates, schedules, and projections to project needs
- Should have worked on providing guidance, interpretation, and ensure compliance with CSV-related regulations, quality manuals, company policies, and procedures
- Should have good documentation practices (GDP).
- Should have experience on creating and executing OQ scripts
- Should have experience on HP ALM / JIRA / qTest Test Management tools
- Should have experience on developing Operations Run Book
- Should have experience on Document Management Tools (TRU, EDMS, DocSpace etc.,)
Validation Test Lead
Should have experience on HP ALM/JIRA/qTest Test Management tools. Should have experience on authoring GxP computer validation and Part 11 related documentation - compliance analysis, Compliance Plan, CSV risk assessment, USR, FRS and User Stories, Global change controls as per GxP standards. Should...
Validation Test Lead
Should have experience on Client ALM/JIRA/test Test Management tools. Should have experience on authoring GxP computer validation and Part related documentation - compliance analysis, Compliance Plan, CSV risk assessment, USR, FRS and User Stories, Global change controls as per GxP standards. Should...
Validation Test Lead
Should have experience on Client ALM/JIRA/test Test Management tools. Should have experience on authoring GxP computer validation and Part 11 related documentation - compliance analysis, Compliance Plan, CSV risk assessment, USR, FRS and User Stories, Global change controls as per GxP standards. Sho...
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