The King’s College London/GSTT new cyclotron and PET Radiochemistry facility (PERL) seeks an experienced Quality Assurance Officer to join its team. The post holder will have responsibility for acting as one of the QA Officers for the PERL. QA duties will focus on being a key point of contact between QA and the PERL radiochemistry team and external stakeholders whilst undertaking QA tasks in support of the PERL.
The PERL facility is based at the St Thomas’ hospital site and is a joint initiative between King’s College London and the Guy’s & St Thomas’ NHS Trust. Its remit includes: 1) production of GMP radiotracers for research and clinical use; 2) the discovery and development of new radiochemistries, labelling methodologies and 3) implementation of new PET radiotracers.
This post will be offered on an indefinite basis
This is a full-time post
- Support the Head of PERL in maintaining the PERL facility and supporting GMP documentation in an MHRA audit ready state. Provide document control for Standard Operating Procedures, Batch Manufacturing Records and Validation protocols.
- Undertake regular review of logs for Micro, Physical and Cleaning Records of the PERL.
- Assist with the preparation and review of manufacturing and validation documentation such as Production and QC batch manufacturing records.
- Lead and act as a QA reviewer and approver for manufacturing/validation documentation, OCC, Dev, CC, CAPA and production records representing the GMP facility
- Act as a point of contact between PERL QA and the PET radiochemistry team.
- Lead internal QA audits ensuring that GMP compliance is met.
- Support the hosting of external audits by regulatory bodies.
- Ensure that the data for the QRM review of OCC, Dev, CC, CAPA, Audit actions/findings, document control/review, training records, EM review, Trending and Maintenance log review are fully documented and available at the time of the QRM.
- Support PERL management quality awareness by bring to their attention significant trends and issues via periodic reporting.
- Identify and assess any non-compliance issues, raise issues with senior/line management and ensure appropriate actions are agreed, implemented and followed up. Be proactive to ensure that regulatory and compliance issues are resolved in a timely manner and do not present barriers to the production of radiotracers.
- Provide advice and guidance on GMP, regulatory and compliance related issues.
- Provide GMP training.
- Research and analyse information from multiple sources in relation to updates to GMP regulations, with a view to amend/modify procedures and interventions in the manufacturing process within PERL.
- Participate and lead in process improvements utilising LEAN principles based on views from users and conveying the detail and rationale in a clear way
- Be proactive in providing quality support for the implementation of new radiopharmaceuticals to the PERL.
- The post holder will be required to work with minimum supervision. They must be able to manage their own time and workload efficiently and effectively. This also requires a confidential and methodical approach with a flexible and adaptable work ethic. They will interlink with other areas of the PET Centre and research groups within the School of Biomedical Engineering & Imaging Sciences and will be required to communicate with them effectively.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
1. Education: Higher degree (e.g. MSc/PhD or equivalent) in chemistry, pharmacy or related discipline or significant relevant experience of 3 years plus in a QA position
2. Knowledge and application of GMP, GCP, QA and current pharmaceutical legislation
3. Demonstrated ability to manage quality exceptions and knowledge and application of a pharmaceutical quality system
4. Experience working in QA in a licensed pharmaceutical production unit
5. Experience of aseptic production processes
6. Training and mentorship skills
7. Excellent verbal & written communication skills including ability to draft documents, e.g., standard operating procedures
8. Project management skills, with the ability to handle several projects at once and prioritise workload, acting on personal initiative and take responsibility for own work to ensure projects are completed
9. Experience of meeting targets and deadlines
10. Strong interpersonal and networking skills, working as part of a multidisciplinary team
11. Flexible approach to hours & duties and ability to work with a variety of people
12. Positive constructive and team-based approach to problem solving
1. Good knowledge of validation including cleaning validation, method validation and CSV
2. Trained auditor, with experience of supplier audits
3. Knowledge of PET and/or SPECT radiotracer synthesis and QC within a Radiochemistry laboratory experience
4. Supervisory experience
5. Experience with automated synthesis equipment
This post is subject to Disclosure and Barring Service clearance.