Quality Assurance ManagerOxford£40,000 £50,000 per annum + benefitsFull time (there may also be the requirement to participate in an out of hours / weekend rota)Fixed-term...
Quality Assurance Manager
£40,000 - £50,000 per annum + benefits
Full time (there may also be the requirement to participate in an out of hours / weekend rota)
Fixed-term for three years (in the first instance), but likely to be extended
Contact Andrew: 0121 728 8456
The postholder will act as Quality Assurance Manager. Reporting to the 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.We are looking for someone with previous experience in Quality Assurance in a pharmaceutical manufacturing facility who has practical experience in administering a wide range of quality systems (QMS). This post would be potentially be an interesting opportunity for someone at senior QA officer level, who is interested, motivated and confident in making their first step into a managerial role, and take charge of running the Quality Management System. This is a unique opportunity to join a facility in the final stages of preparation for licensing, at a time where you will still be able to make the QMS your own and will be able to shape the future development ointo Phase 2 activities. We therefore ideally require someone with prior experience of releasing batches of unlicensed products or performing batch review activities prior to QP certification for commercial products. The ideal candidate would have prior experience in working within a clinical trials manufacturing setting. The role will work closely with the site QP so experience of acting as QP delegate for routine duties would be advantageous.
- Management of all QA activities and line management of QA staff
- 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 Unit Head, OUH Trust representative and Qualified Person to define overall policy and objectives.
- Acting as QP delegate for routine duties for investigational medicinal products.
- Responsible for managing and implementing the facility's audit programme.
- Ensure all deviations are appropriately managed and corrective and preventative actions are implemented.
Selection criteria - 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.
- 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.Experience of working unsupervised under own initiative on a day-to-day basis.
- The ability to adhere to statutory health and safety and radiation safety guidelines pertaining to a radiochemistry laboratory.
- Experience of batch review.
- Experience of review and approval of manufacturing and analytical method validation documentation.
- Knowledge of GLP and GCP.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.