Manager - PVQA - 4092
Job Description
1. Compliance & Regulatory Adherence - Ensure adherence to GPV, GCP, SOP, Protocols, and ethical guidelines.
2. SOP Management - SOP review and Management
3. Training and process improvement: Training management of CT and PV staff
4. 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
5. Quality Management function: (Change control, deviation management and CAPA handling)