Job title: Qualified Person (IMP)
Location: Oxford (hybrid)
Salary: Competitive
SRG are supporting a world leading, innovative biomanufacturer in their search for a Qualified Person (QP), based in Oxford. This is a long-term contract position (5 years).
This is an exciting opportunity an exciting opportunity for a QP to join their Clinical Biomanufacturing Facility. The successful candidate will be named on the MHRA licence MIA (IMP).
You will be responsible for certifying and ensuring compliance with developing regulations of the IMPs and ATMPs as well as partial batch manufacture, clinical trials labelling and final certification to trial.
You will:
- Perform QP legal duties and responsibilities conducted under the MHRA MIA (IMP) 21584, including QP certification to clinical trial of site and externally manufactured products in Oxford and elsewhere.
- Ensure that QMS remains in proper order to support competent decision making for IMP certification and release and in compliance with all relevant GMP guidelines as are defined in EudraLex Volume IV.
- Ensure compliance with developing regulatory requirements including relating to implementation of the clinical trials regulation and major updates in guidelines such as to EU GMP Annex 1.
- Support with, or lead on training, self-inspections, external audits, risk assessments, change controls, CAPAs and investigations including deviations, out of specifications, complaints and product recalls.
- Manage work by contract QPs
- Provide advice to external and internal staff on the interpretation and application of current legislation and guidance for novel manufacturing processes, QC testing strategies and product types so that they meet the requirements of the MHRA and EU GMP. This will include leading dialogue with the MHRA and the Innovations Office.
- Review and approve Quality/Technical Agreements.
- You may occasionally be required to work outside your normal working hours.
- Participate in and support the public engagement and widening access activities of the Department. This is anticipated to be not more than 2 days per year.
Requirements:
- Degree in chemistry, biology or pharmacy or equivalent
- Member or higher position of Royal Pharmaceutical Society, the Royal Society of Biology or the Royal Society of Chemistry
- Named on 'Register of Eligible QPs' of your professional body
- Other qualifications may be permissible for eligible QPs who have not qualified under the permanent provisions or from outside the UK, subject to review
- Experience with the manufacture of biological, sterile medicinal products
- Competent and experienced in managing all aspects of Quality Assurance within a GMP regulated environment
- Sound knowledge of EU GMP guidelines and evidenced ability to interpret these for early-phase IMPs and ATMPs
- Experience of leading qualification/validation of assays, manufacturing process and equipment and facilities.
- Experienced Pharmaceutical Auditor
- Previous managerial or supervisory experience with proven leadership skills
- Significant scientific and / or technical expertise working in a GxP environment, along with several years' experience in a manufacturing or Quality role
You'll receive:
- An excellent contributory pension scheme
- 38 days annual leave
- A comprehensive range of childcare services
- Cycle loan scheme
- Discounted bus travel and Season Ticket travel loans
If you are interested in finding out more, please apply using the provided link or send a copy of your CV directly to Shazad on or contact directly on for a confidential conversation.
SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.