Title: Qualified Person
Location: Based Norfolk
Salary: Highly competitive salary + benefits available DOE
Evolve Consultant: Claire Handley
Our client has a new opportunity for a Qualified Person to join them at their manufacturing site in Norfolk. The role will undertake all QP responsibilities across the organisation and compliance of the site to ensure it meets manufacturing standards.
Essential Requirements for the Qualified Person
* You will be a Qualified Person in the UK within the Pharmaceutical or Medical Device industry.
* A minimum of 5 years’ experience as a QP which ideally will involve prior experience in the certification of sterile dosage forms (either terminally sterile or aseptic).
* Educated to degree level in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology.
Role Responsibilities for the Qualified Person
* Timely release of all drug products, medical devices and unlicenced drug products.
* Ensuring suitable contracts and technical agreements are prepared and implemented relating to the manufacture, packaging, testing and distribution of medicinal products.
* Notify senior management of any issues related to GMP, product quality and any other matter than requires their attention.
* Participating/leading in the review of any complaint, deviation investigation, or product recall.
* Provide support to the auditing of of contractors and key suppliers against Marketing Authorisations and relevant GxPs.
* Inspect contractors' facilities and production documentation at intervals to establish and maintain working relationships with people in positions of responsibility and maintain confidence in their application of GxP and requiements of Marketing Authorisations.
* Review and approve SOP's and other relevant GMP documents relating to the manufacture, labelling and assembly operation, storage, distribution and QC testing of drug products.
* Coach staff in GxP requirements.
2 stage process
Interested? Please get in contact with us on (phone number removed) to speak to Andy or Claire.
Evolve is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions
Product Quality Assurance
Packaging And Labeling