Qa jobs in United Kingdom

The Senior Production-QC Radiochemist will work as part of a team of radiochemists involved in the production and/or QC of radiopharmaceuticals in accordance with GMP requirements to set production schedules.

• Duties include the development of new tracers by performing practical validation work as directed by more senior radiochemists.

• To support GMP compliance by performing practical validation work and updating SOPs as directed by more senior radiochemists.

• To support the training of other staff members, performing routine tasks and administrative work, and acting as the contact with the clinical team on occasions when the need arises or is assigned to.

This is a full time post, and you will be offered an indefinite contract.

The PET Centre is part of Guys & St Thomas NHS Foundation Trust and Kings College London within the School of Biomedical Engineering & Imaging Sciences.

The Positron Emitting Radiopharmaceutical Laboratory or PERL plays a crucial role in the clinical PET Centre, serving over 8,000 patients and research participants annually from South-East London and beyond. It is an integral part of both King\'s College London\'s School of Biomedical Engineering and Imaging Sciences and Guy\'s & St Thomas\'s National Health Service Foundation Trust. Our PET Center, which is now equipped with 2 Total Body PET scanners, relies heavily on the PERL facility for the supply of radiopharmaceuticals.

Comprising two GMP clean rooms, a QC laboratory, and an R&D laboratory with a total of 24 hot cells, the PERL facility is equipped with a PETtrace high-energy cyclotron fitted with both liquid and solid targetry and various dispensing units, calibrators, and analysis equipment. It operates under a Specials manufacturing license, currently producing 18Ffluorodeoxyglucose FDG, 11C methionine, 18F FSPG and 18F DCFPyL-PSMA routinely, with ongoing development of additional radiopharmaceuticals. We are looking to expand the range of radiopharmaceuticals available for clinical use, including F-18, C-11, Cu-64 and Zr-89 based radiopharmaceuticals.

• Duties include the development of new tracers by performing practical validation work as directed by more senior radiochemists; to support GMP compliance by performing practical validation work and updating SOPs as directed by more senior radiochemists; and to support the training of other staff members, performing routine tasks and administrative work and acting as the contact with the clinical team on occasions when the need arises or is assigned to.
• Undertake commissioning, validation, production and QC analysis of PET radiotracers in accordance with GMP procedures.
• Carry out practical validation work for development or GMP compliance as directed by a senior radiochemist.
• Perform routine tests, inspections and maintenance on laboratory equipment and infrastructure.
• Ensure accurate records are maintained of all production, QC, tests, inspections and maintenance work in accordance with SOPs.
• Participate in a production and QC rota system to cover 05:00 to 18:30 assigned by the Production, QC and Operations manager. Time schedule may vary due to service need and changes will be subject to consultation.
• Comply with local rules for working in a controlled area.
• Follow strict aseptic techniques when working in the isolator hot-cell.
• Communicating technical problems with equipment or processes to other members of the team, cyclotron engineers, clinicians and to senior members of staff.
• Updating and writing SOPs, logs and records and investigational reports where and when necessary or as is delegated to ensure they are accurate.
• Scheduling their own priorities to ensure that tasks allocated on a daily or weekly basis are completed as required.
• Perform routine administrative tasks such as ordering and recording of materials as directed.
• Be trained on and apply syntheses and analytical methods for newly introduced radiotracers for research and clinical GMP use.
• Train other staff, researchers or students in production or QC processes as required.
• In the occasional non-availability of senior staff, act as the point of contact between the PET production and QC teams and the clinical team as appropriate.
• Engage with staff training programmes and be competent to perform at least three different GMP manufacturing processes on different synthesis platforms.
• Engage with Production staff training and be competent to operate the hot-cells, automated synthesis platforms and dispensing platforms.
• Engage with QC staff training programme and be competent to operate all of the QC equipment in the laboratory, including automatic injection HPLC and various detectors (e.g., DAD, Conductivity, ECD, MCA detector, GC, TLC), PTS for GMP radiotracer productions.
• After appropriate training, be able to operate the PET Trace Cyclotron for production of radionuclides to be used in synthesis processes.
• Raise Quality Exception Reports as required such as Occurrences, Deviations, Change Controls.
• Raise Quality Exception Reports and investigate quality exceptions including completing Root Cause Analyses and drafting Quality Exception Reports for approval by QA.

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.

• Degree in chemistry or pharmacy OR Broad vocational experience, acquired through a combination of job-related vocational training and considerable on the job experience, demonstrating development through involvement in a series of progressively more demanding relevant work/roles.

• Knowledge of PET radiotracer synthesis and QC
• Radiochemistry/radiopharmacy laboratory experience
• Practical experience with the production and/or QC of PET Radiopharmaceuticals
• Knowledge of and proven record in adhering to the principles of GLP and GMP
• Knowledge of Ionising Radiation protection regulations
• Experience with automated synthesis equipment
• Experience of production to GMP standards

• Ability to amend documents e.g. SOPs
• Excellent time keeping, reliable, flexible and able to work with a variety of people with a flexible approach to hours and duties and ability to work on own initiative and in a multi-disciplinary team

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

£45,031 to £52,514 a year King\'s Grade 6, including LWA