Qualified Person - QP

This is an exciting opportunity to utilise your skills and experiences to really make a difference within the company.

The Qualified Person will support the development, maintenance and monitoring of the Quality Management Systems in line with regulatory expectations and guidelines provided by the company.

Responsibilities include:

- Qualified Person batch certification in accordance with European legislation for both Investigational Medicinal Products and Commercial Products
- Provide QA input to all Site activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing procedures and analytical procedures.
- Participate in business validation activities including review and approval protocols for analytical methods, manufacturing processes, production and packaging equipment and cleaning procedures.
- Develop and lead the audit of suppliers and manage the vendor assurance programme and perform Q.P. declaration for API's used in the manufacture of finished products..
- Support and implement programs to assure compliance with regulatory (MHRA and others) requirements, as well as the standards for quality and performance set by internal and external customers
- Provide an externally facing role maintaining relationships with clients, regulators and other professional bodies
- Support the Sites training activities in all matters related to GMP.

Person specification

- Experience of Clinical Trials Manufacturing
- Experience in leading MHRA/FDA inspections essential
- Must have Production experience (Pharma)
- Must have 5 to 10 years in QA (Pharma)
- Strong team leadership and development skills.

If you are interested in this amazing opportunity, and feel you have the skills and experiences required, please forward an updated CV to Jade Tetlow or call 0207 758 7311 for further details.To find out more about Real please visit www.realstaffing.com