The Role
This is an exciting opportunity for someone develop their career as a Responsible Person in a market leading, global healthcare company. You’ll be responsible for ensuring their supply chain operations comply with all relevant quality legislation.
1. Acts as the Responsible Person for the business.
2. Act as or deputises for the person responsible for regulatory compliance as per requirements of Article 15 of REGULATION (EU) 2017/745
3. Act as or deputise for the Management Representative relating to the development and continuous improvement of the processes needed for the Quality Management System (QMS)
4. Development and continuous improvement of the processes needed for the QMS
5. Promote the awareness of the QMS and any applicable regulatory requirements
6. Leads external supplier audit and qualification.
7. Manages GDP and GMP inspections by competent authorities and customers.
8. Implements and maintains Operations SOPs
You
To apply for this role as Responsible Person our client is hoping for someone with the following skills and experience;
9. Ample experience in carrying out the Responsible Person role within a pharma company
10. Ideally experienced with imports
11. Medical devices experience is desirable
12. Management of a QMS
13. Excellent knowledge of quality management
14. Internal and external auditing experience is highly advantageous