Qualified Person (QP)
A unique and exciting Qualified Person (QP) role is available at the Clinical BioManufacturing Facility (CBF) in Oxford. The CBF is part of the Jenner Institute (Nuffield Department of Medicine, University of Oxford) and has the busiest pipeline of any academic GMP facility in the UK for Phase I/II clinical trials. Recent CBF activities have included the production of innovative recombinant protein, adenovirus vectored, and VLP vaccines against pathogens which cause major global diseases such as malaria, Chikungunya, and Zika. We are also working in close collaboration with scientists at the Jenner Institute and major funding bodies to develop vaccines against emerging pathogens for future epidemic preparedness.
The main responsibilities of the QP role will be to certify externally manufactured and in-house production batches of investigational medicinal products (IMPs) for GMP compliance, and to provide QP certification for clinical release to trials both in Europe and worldwide. As many of the products and processes developed at the CBF are novel, the role will involve close interaction with the Sponsor and, where formal regulatory support is required, also with the MHRA. For externally manufactured products, QP oversight will be required including auditing activities.
The ideal candidate will be eligible to act as a QP in the UK and have experience in the manufacture of sterile investigational medicinal products (IMPs). They will be expected to have a strong scientific and/or technical background and an in-depth knowledge of EU directives, regulations and guidelines. They are also expected to be experienced in Quality Management Systems, performing reviews of GMP records, performing and hosting audits and leading or providing support for critical activities including deviations, out of specification investigations, complaints and recalls.
This is an opportunity to join a team working at the cutting edge of vaccine development in a unique academic setting. We are therefore looking for a motivated team player able to rise to the challenges of working with previously untested innovative products.
For full job description click here.
This post is offered on a full-time, fixed-term basis until 31 July 2021 in the first instance.
All applicants must complete a short application form and upload a CV and supporting statement.
Only applications received before 12.00 noon on Friday 13 May 2019 will be considered.
Salary: Grade 9 – £47,263 – £54,765 p.a.
Contact Person: HR Officer Vacancy ID: 139770
Contact Phone: 01865 617971
Contact Email: firstname.lastname@example.org
For any informal enquiries, please contact: Cath Green at email@example.com
To apply, please click here.
Qualified Person (QP)
Catalent Pharma Solutions are looking to recruit an experienced Qualified Person (QP) to join our team at our Nottingham site.
The role of QP is primarily to release batches of Investigational Medical Products (IMP) to clients or the clinic according to 2001/83/EC as amended.
In the role of QP you will ensure that all manufacturing steps are performed in accordance with 2003/94/EC and Eudralex Volume 4.
- Perform all legal duties as defined in 2001/83/EC as amended.
- Responsible for all routine duties as defined in 2001/83/EC as amended. QP Release/Certification of IMP batches to Clients/Clinic
- Participates in the auditing of all contractors and suppliers.
- Reviews all manufacturing Batch Records for each IMP batch including batch related deviations.
- Reviews Pharmaceutical Quality Systems used such as Change Control, CAPA, Internal Audit, non-conformances, Quality Agreements and ensure compliance with site SOPs.
- Support site Client Audits or Regulatory Inspections.
- Participate in Product Quality Reviews.
- Responsible for any Product Recall.
- Provide support for the materials management approval process, including performing risk assessments and audits as required.
- Ensure that all work is conducted in responsible and safe manner in accordance with Molecular Profiles Health and Safety policies and ensure that all Health and Safety considerations are appropriately documented
- Eligible to act as a QP in the UK
- A degree in a science-based subject
- An in-depth understanding of GMP Quality Systems relating to Pharmaceutical Development and Manufacturing of clinical trial products.
- Knowledge of EU and US GMP regulations
- Trained to conduct audits, internal and external to required GMP standards
- Experience of Client/Regulatory audits
Our 7 standard leadership competencies
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Competitive salary
- Discretionary annual bonus
- Contributory Pension scheme
- 25 days holiday – plus bank holidays
- Life Assurance
- Healthcare provision
- Free parking
- Childcare vouchers
- Health Shield
- Learning & Development opportunities
To apply email Iain.Macdonald@catalent.com.