Qualified Person

We are currently looking for a Qualified Person to join a leading Biopharmaceutical company based in the Oxfordshire area. As the Qualified Person this will be a great opportunity for an outstanding candidate to join a diverse team, supporting the manufacture of innovative medicines in development with the potential to have world-changing impact.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:

1. As the Qualified Person, your role entails certifying Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) for usage, ensuring adherence to both current and evolving regulatory standards.

2. Your duties will encompass issuing QP declarations for imported products and overseeing a spectrum of QP activities, including certifying partial batch manufacturing, managing clinical trial labelling processes, and final certification for trials.

3. In your capacity as the Qualified Person, you'll actively support all activities within the CBF (Clinical BioManufacturing Facility) and offer expert guidance on research and manufacturing initiatives.

4. This position holds significant importance in ensuring the operational efficiency and adherence to quality standards within the CBF. Its uniqueness and diversity stem from the distinctive nature and breadth of translational products manufactured within the facility.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:

1. Relevant degree in a chemistry, biology or pharmacy and be a member or higher position of Royal Pharmaceutical Society, the Royal Society of Biology or the Royal Society of Chemistry. You will be named on the Register of Eligible QPs' of your professional body and be eligible to be a Qualified Person who can be named on the CBF's MIA (IMP).

2. Proven industry experience in managerial or supervisory experience with proven leadership skills, with excellent interpersonal skills with the ability to work with and influence senior members of academic staff.

3. A working knowledge and practical experience with managing all aspects of Quality Assurance within a GMP regulated environment, together with having sound knowledge of EU GMP guidelines (EudraLex Volume 4) and evidenced ability to interpret these for early-phase IMPs and ATMPs.

Key Words: QP, Qualified Person, IMP, ATMP, GMP, Oxfordshire, Quality, Pharmaceutical, Biopharmaceutical, Chemistry, Manufacturing.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.