Senior PV Auditor
24 days ago
Hamlyn Williams has partnered with a global biopharmaceutical company that is in in a big phase of growth that specializes in CNS, Nephrology and Oncology. Due to expansion, the company is looking
The role is a part of a dynamic team performing global pharmacovigilance risk assessments, managing and performing pharmacovigilance audits, including pre- and post-audit activities such as authoring audit reports and/or reviewing audit reports.
Please see a summary:
- Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities
- Plan, supervise, conduct, and support internal and external GxP audits
- Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
- Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
- Support the preparation for GxP inspections
- Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution
This is a great opportunity for someone with PV QA experience to step up into a Senior PV Auditor role.