CK Science are working exclusively on an assignment for a Qualified Person to join a global Pharma company based in Hertfordshire.
The company work on discovery of new molecules both NCEs and NBEs, in the branded generics markets and they also market APIs. They employ 6000 people in over 80 countries and have twelve manufacturing facilities and five R&D centres across Europe, Asia, Africa and South America. They are currently selling products in over 70 countries and are one of the most exciting and expanding pharma companies in the world today.
This role is based in the Generics arm of the business and you will act as a Qualified Person in accordance with EU GMP to provide final certification/release along with Quality Assurance a Regulatory support. You will perform audits of third party providers in order to ensure EU GMP standards have been achieved and will support the internal audit programme to enable permanent inspection readiness. You will also provide QP GMP declarations in support of importation activities and will be expected to maintain an up to date awareness of regulatory issues.
Qualifications and experience:
It is essential that you are a fully qualified QP and that you are experienced with final certification/release within the EU. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role. A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous.
The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Generics QP experience would be adistinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome.
This is a key role for the company and is a sign of their ambition for the future. The position is full time, permanent and it is envisaged that the role will be based on site.
This role is being handled exclusively by CK Science and we would be happy to discuss details further at your convenience.
For more information or to apply for this Qualified Person role, please contact Jason Johal at CK Science on 01438 723 500 or email firstname.lastname@example.org. Please quote reference ST21673 in all correspondence.