Senior CSV Auditor
about 1 month 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 for an experienced CSV Auditor to join the company on a permanent basis.
The main task is the development and execution of the Global CSV Audit Strategy and Global CSV Audit Plan.
This includes defining risk standards and methodologies, audit methodology and best practices to ensure consistency of approach, the role involves but is not limited to:
- Develop, maintain and provide input to an adequate audit plan for global, regional and local, computerised systems and compliance processes
- Plan, supervise, conduct, and support internal and external CSV audits
- Support the development, implementation, continuous improvement and documentation of Companies’ Quality System
- Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
- Coordinate/Support the preparation for GxP inspections
- Support the validated state of computerised systems
- Provide business support as Global Quality for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement)
If you are an experienced CSV Auditor looking for a new challenge, please don’t hesitate to get in touch.