Qualified Person
- Ruislip, Middlesex
- £60,000 per annum
- 3 applications
- Job type: Permanent, full-time
- Date:
- Reference: 21151031
Qualified Person is required by this major Pharma organisation. You will be responsible for the full certification of products as well as conduction of in depth audits- whilst being able to display as well as communicate an in depth knowledge of GMP regulatory standards, licensing and sterile production standards.
- Responsibility for the review and approval of SOP's, review and approval of study protocols as well as internal/external auditing
- Auditing for GMP,GCP GDP and GLP purposes
- Experienced in quality management systems covering all aspects of licensed manufacturing sites
- Troubleshooting of of all GMP, GCP and GLP issues
- Provide input into the regulatory strategy for the development of pharma products to the UK
- Regular liaison with the MHRA/regulatory authority
- Working cross functionally with Pharmacovgilance, Reg Affairs and clinical research
- Involvement in all aspects of sterile production
- Execute and deliver all training programmes required for staff members
- Maintaining all professional knowledge databases
- Ad hoc projects
