Company:
Katalyst Healthcares & Life Sciences
Location: New Brunswick
Closing Date: 26/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities & Requirements:
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 Client ALM/JIRA/test Test Management tools
Should have experience on developing Operations Run Book
Should have experience on Document Management Tools (TRU, EDMS, DocSpace etc.,)
Responsibilities & Requirements:
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 Client ALM/JIRA/test Test Management tools
Should have experience on developing Operations Run Book
Should have experience on Document Management Tools (TRU, EDMS, DocSpace etc.,)
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