The new cyclotron and PET Radiochemistry facility (the PERL) at KCL/NHS Trust St Thomas' Campus, London has the following remit: 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 is a key role within the PERL QA 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 whilst undertaking QA tasks in support of the PERL.
This post will be offered on an indefinite basis
This is a full-time post
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
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. SOPs
8. Able to handle several projects at once and prioritise including ability to act on personal initiative and take responsibility for own work and ensuring projects are completed
9. Experience of working to targets and deadlines
10. Ability to work on own initiative and in a multi-disciplinary 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 Occupational Health clearance.
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