Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities.
Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate
SOPs and current regulations.
Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance.
Provide quality assurance oversight for system related issues (Test incidents, issues, etc.)
Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
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