| Role | Location | Salary |
|---|---|---|
| Technical & Engineering - Qualified Person | Kent | £50,000 – £55,000 |
| Division | Reference | Consultant |
| Technical & Engineering | PV 9527 CT | CT |
Reporting to the Technical Manager, The Qualified Person (QP) will be experienced QP and have worked within a Sterile Environment managing people & delivering effective, safe and compliant management of the Quality Assurance function.
• Input into the Regulatory Strategy for the development of pharmaceutical products in the EU
• Develop document procedures to assemble relevant technical files and annual reports
• Responsible for the release/rejection of pharmaceutical products
• MHRA contact for European products
• Regulate all GMP & QA procedures connected with manufactured pharmaceutical products
• Act as the Qualified Person (QP) relating to the detection, assessment, understanding and prevention of adverse effects of manufactured products
• Manage External and internal audit programs for all pharmaceutical products
• Review QA & SOPs
• Report Annual Product Reviews for both Licensed and Contract Products
• Review and approve change requests
• To assess changes to EU Medical device and Pharmaceutical regulations and implement changes accordingly
The Qualified Person (QP) will have practical practical application of Pharmaceutical regulatory requirements and regulations
• EU Qualified Person (MHRA approved)
• Substantial experience working in a pharmaceutical or medical device manufacturing quality function
• Working knowledge of the principles and guidelines for GMP.’
• Leadership experience and management qualifications.
The anticipated salary for the role of Qualified Person (QP) is likely Circa £50,000 – £55,000 depending on skills and experience for this permanent position.