- Compliance & Regulatory Adherence - Ensure adherence to GPV, GCP, SOP, Protocols, and ethical guidelines.
- SOP Management - SOP review and Management
- Training and process improvement: Training management of CT and PV staff
- Audits & Inspections a. Conduct internal/System audit of CT and PV function b. Handling of regulatory inspection c. Project based audit (i.e. protocol review, TMF audit, site audit, CSR review) & QA certification d. Quality review of PV documents e. Vendor/CRO qualification
- Quality Management function: (Change control, deviation management and CAPA handling)