Senior Radiopharmaceutical Scientist | Guy's and St Thomas' NHS Foundation Trust
| Posting date: | 09 April 2024 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £51,488 - £57,802 p.a inc of HCA (pro rata) |
| Hours: | Full time |
| Closing date: | 09 May 2024 |
| Location: | London, SE1 9RT |
| Company: | Guys and St Thomas NHS Foundation Trust |
| Job type: | Contract |
| Job reference: | 6210065/196-LIS8353 |
Summary
We are looking for an experienced, enthusiastic and flexible Radiopharmaceutical Scientist to join our team at Guy’s and St Thomas’ NHS Foundation Trust (GSTT). The successful applicant will work closely with the Pharmacy QA team and Radiopharmacy to help develop and maintain the quality management system in addition to routine production activities.
The successful candidate will take part in daily manufacturing and releasing activities as well as line management duties for the technicians within the team. They will also be expected to provide scientific support in process and product development in collaboration with the Production and Validation lead.
The Guy’s Radiopharmacy is a very busy working environment that provides a diverse range of services including production of diagnostic radiopharmaceuticals for our own hospitals and external customers including both Tc-99m and Gallium-68 labelled products, dispensing of therapeutic doses as well as running a thriving cell labelling service. We also provide the laboratory support for in vitro studies such as red cell mass and GFR tests.
The unit holds both an MS and MIA(IMP) license and is therefore involved in a number of exciting clinical trials. This is a fast paced environment suitable for someone who is looking to be part of our team.
General
1. To participate in the preparation and supply of radiopharmaceuticals to the Nuclear Medicine Directorate and its customers, ensuring a high quality service is provided at all times.
2. To release manufactured radiopharmaceuticals for clinical use under the arrangement of the unit’s “Specials” manufacturing licence.
3. To ensure that all activities undertaken by all staff within the unit meet current legislation such as GMP/GDP, GCP, Medicines act, H & S, COSSH, and that all work documentation and procedures are in accordance being followed.
4. To be responsible for ensuring that the stock control system and control of sundry items is suitably operating at all times to ensure smooth running of the radiopharmacy operations.
Operational Management and Supervision
1. To be jointly responsible for the work flow and planning of all activities to ensure a timely completion of all products and service requirements.
2. To supervise and monitor performance of technical staff performing all production activities.
3. To ensure the quality systems are followed and reported as required ensuring the provision of a high quality preparative service to the Trust and external customers.
4. In order to maintain continuity of service in times of staff absenteeism and/or annual leave there is the expectation as a senior member to step in and fulfil any obligations that are important to the provision of service.
5. To supervise the Housekeeping staff in performing the daily and monthly cleaning program for the unit and to ensure cleans are routinely performed to the high grade required.
6. To undertake recruitment and selection of new technician staff for the radiopharmacy unit when necessary and after appropriate training.
Quality
1. To lead by example the adherence to Quality Assurance and Radiopharmacy procedures ensuring that they are followed by all staff members. To monitor the compliance to procedures and to report any divergence from these procedures to line management.
2. To ensure all quality control monitoring procedures are performed routinely by allocated staff and that the monitoring is documented accurately and in a timely manner. Any exception incurred to the quality control program must be reported to line management and documented.
3. To ensure all the requirements of the radiopharmacy unit’s master validation plan is completed in full and ready for reporting at any time.
4. To ensure all exceptions to quality procedures and service is strictly documented and reported to QA and line management in a timely manner. Agreed action plans to be managed and completed within the agreed time frame.
5. To maintain the equipment in the radiopharmacy in a safe and satisfactory condition and keep records of the maintenance. To maintain the radiopharmacy unit in a state of audit-readiness.
6. To ensure that all documentation is maintained and filed in an organised manner, and is readily available on demand. Documented records no longer required for use must be archived accordingly to ensure traceability.
7. Promote a culture of continuous improvement to ensure that that processes are optimized.
Training and Development
1. To assess and establish training requirements from performance monitoring of technical staff.
2. To first line train all technical staff, including rotational staff and student NVQ technicians, in radiopharmacy aseptic activities.
3. To ensure the personnel training and competency assessment program is adhered to by all staff. Training for all radiopharmacy staff in standard operating procedures must be kept up to date and that personnel training logs are complete and ready for inspection at any time.
4. To train and assess new housekeeping staff to the unit in all appropriate procedures to their line of work.
5. To perform the induction and appraisal process of all new staff to the radiopharmacy unit.
Clinical Trials
1. To review all new trials requiring aseptic preparation to ensure that the protocol, authorisation and ethical approval meets the requirements of EU Clinical Trials Directive. To ensure that the Radiopharmacy unit is sufficiently resourced in terms of equipment and staff to undertake the trial.
2. To develop documents for the preparation of the trial and to ensure all staff involved in any aspect of the trial are suitably trained.
3. To ensure all trial documentation and trial material meet the requirements of GMP and GCP and are appropriately approved before use.
4. To be responsible for all pharmacy aspects of the trial to ensure compliance with GMP and GCP and that the facilities and documentation are suitable for audit when required.
Others
1. To assist in research and in service development in accordance with jointly agreed objectives between the Chief Radiopharmaceutical Scientist.
2. To take a leading role in developing the Gallium-68 service and ensure a robust system is implemented in order to meet demand.
3. Take a lead on new process validation and provide scientific support to the day to day service.
4. To provide other reasonable duties as specified by the Chief Radiopharmaceutical Scientist.
This advert closes on Monday 22 Apr 2024