Oxfordshire, United Kingdom
£42,000 - £47,000
almost 2 years ago
The postholder will act as Quality Assurance Manager in the PET Radiopharmacy Oxford (PROx).
Reporting to the PROx Unit Head, the postholder will lead the implementation and maintenance of the facility’s pharmaceutical quality systems, ensuring that procedures and documentation comply with GMP and MHRA guidelines and EU legislation. The facility will operate as a multi-skilled team to ensure continued development of all staff and the postholder will actively participate in providing regulatory expertise, guidance and training for the facility personnel.
This post provides a unique opportunity to contribute to the set-up of a new unit that will deliver PET tracers for clinical research and develop novel tracer production for first in human studies.
- Management of all QA activities and line management of QA staff within PROx.
- Ensuring all policies and procedures are robust and effectively implemented in line with both the quality systems of the unit and current legislation and guidance.
- Reporting compliance status of the facility to the OUHT license holder and the Qualified Person.
- Leading the preparation of reports of the quality system status for senior management review and providing ideas and strategic guidance for continuous improvement of the quality system.
- Responsible for management and day-to-day operation of the quality system. Liaise with the PROx Unit Head, OUH Trust representative and Qualified Person to define overall policy and objectives.
- Suggesting solutions on ways to meet legal requirements within the constraints of an academic setting, and provide QA review and approval for validation plans, protocols and reports.
- Acting as releasing officer for release of unlicensed medicinal products (“specials”) where trained and deemed competent.
- Acting as QP delegate for routine duties for investigational medicinal products.
- Responsible for managing and implementing the facility’s audit programme.
- Taking a lead for training and developing PROx staff in GMP and relevant legislation and guidance. Taking responsibility to ensure that the evolving regulatory requirements are continuously implemented. Providing strategic guidance to the production and QC departments on how to implement quality requirements.
- Nominated host for inspections from external regulatory bodies and clients.
- Preparing or approving SOPs and work instructions and ensuring that documentation is effectively implemented, monitoring compliance with established procedures and practices.
- Ensure all deviations are appropriately managed and corrective and preventative actions are implemented.
- Responsible for ensuring the supplier management programme is followed by all staff in the facility: Approval and monitoring of suppliers, materials and service providers. Approve specifications for, and approve or reject, starting materials and packaging materials.
- Participation in a flexible release rota, including weekends where required.
- Continued personal development and education as needed to ensure up-to-date knowledge and understanding of current legislation and guidance relative to GMP and production of PET radiopharmaceuticals and to be responsible for the training of individuals working within the facility.
- Participating in management reviews of process performance, product quality and of the quality management system, when required.
- Participating and contributing to group discussions, presenting at internal and external meetings, in particular networking with other departments and collaborators who use quality systems.
- To act at all times in the interests of the department to ensure good manufacturing and control laboratory practice.
- To be accountable for their own professional conduct within the Group.
- To ensure that work in the facility is conducted safely and, in particular, persons undertaking the work do so using appropriate safety procedures and in the dedicated areas.
- To participate in rotas and tasks that ensure the smooth running of the facility.
- To comply with University and local rules with regards to purchasing and financial procedure.
- To maintain confidentiality regarding research data when interacting with non-collaborating workers.
- To maintain an Honorary Contract with Oxford University Hospitals NHS Trust.
- To undertake duties as may be required from time to time that are commensurate with the grade and responsibilities of the post.
- To conduct him or herself with due regard to the University Equal Opportunities and Data Protection policies.
The successful applicant will be expected to meet the following criteria:
- BSc/MSc degree in a relevant science subject.
- Significant experience in a quality assurance role in a licensed manufacturing environment within the pharmaceutical industry or the NHS.
- Comprehensive understanding and experience of working in accordance to EU GMP and MHRA regulatory guidelines.
- Experience in quality systems including change control, deviations and documentation management.
- Attention to detail and the ability to keep accurate and ordered records to satisfy statutory requirements.
- Experience of undertaking and supervising internal and external audits.
- Comprehensive understanding of validation concepts and knowledge of process validation.
- Prior exposure to working within a clinical trials environment.
- Experience in materials management including risk assessment of supply chains.
- Practical experience of implementing risk management.
- Ability, skills and confidence to communicate effectively in English, both orally and in writing, scientific and safety information to a variety of audiences and in a range of contexts.
- Able to work closely and co-operatively with others.
- Reliability and flexibility.
- Experience of working unsupervised under own initiative on a day-to-day basis.
- Ability, skills and experience to deal effectively with conflicting priorities and prioritise tasks under pressure.
- The ability to adhere to statutory health and safety and radiation safety guidelines pertaining to a radiochemistry laboratory.
- Computer literacy with knowledge and experience of databases.
- Experience of batch review.
- Experience of review and approval of manufacturing and analytical method validation documentation.
- Knowledge of GLP and GCP.
- Experience of environmental monitoring.
- Experience of electronic document management and LIMS systems.
- Experience of releasing specials.
- Previous involvement in process improvements.