Continuously improve the TAPI cGxP Computerized Systems policies, standards, procedures, tools and training.
Manage site inspection readiness and support with regards to globally managed Computerized Systems.
Guide TAPI Sites IT and IT QA on inspections trends, observations, authorities expectations and best practices that can mitigate gaps.
Deliver training programs to TAPI Computerized systems owners.
Support sites with any IT related project(s) as required.
Support sites in with computer systems validation, infrastructure qualification and systems life cycle management, together with any remediation needed.
Conduct GxP computerized systems gap assessments/evaluations with applicable regulations
Provide QA IT review and approval on all globally managed Computerized System deliverables.
For some globally managed Computerized System, provide QA IT review and approval on the System deliverables, and for others, represent site users, as System Business Owner.