Katalyst Healthcares & Life Sciences
Validation Test Lead
Katalyst Healthcares & Life Sciences, New Brunswick, New Jersey, us, 08933
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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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.).
#J-18808-Ljbffr