We have a new opportunity for a Validation Radiochemist to join our Radiopharmacy team.
This is a full-time position working 40 hours a week. Our site's operational hours are 24/6 with operational hours from 00:00 to 20:00, so shift work is required.
You should be a scientific graduate with a scientific background, ideally with experience in (radio) pharmaceutical manufacture in a GMP environment.
To be successful in this role you will demonstrate:
* Excellent verbal and written communication skills, analytical skills, a logical approach to problem solving, and good attention to detail. As an effective team member, you will have great organisational skills with the ability to work under pressure.
* Be educated to a degree level in a related scientific discipline or able to demonstrate relevant experience.
* Ideally, be able to demonstrate experience in Radiochemistry or related disciplines.
* Ideally, be able to demonstrate knowledge of GMP, validation, and relevant regulations.
* Validation experience (including laboratory equipment and process validation) would be advantageous.
* Previous experience of operating in a GMP grade C cleanroom, operation of a GMP grade A isolator, and/or distribution of radiopharmaceuticals would be advantageous.
Please note that we will be interviewing throughout the duration of this advert. Therefore, if you are interested in this role, an early application is advised as we may close the advert prior to the advertised date.
Validation
Support validation activities for new products/processes in compliance with GMP and pharmacopeia standards.
Assist with maintaining validation compliance for existing products.
Support QA team with audits and generate validation lifecycle documentation (VMP, URS, DQ, IQ, OQ, PQ, PV).
Create and execute RQ protocols for new equipment/processes and support RMS approvals.
Assist CMC team with product portfolio management for CMOs, including auditing and process development.
Staff
Support staff training and development.
Share best practices and develop troubleshooting procedures with the CMC team.
Maintenance
Assist with calibration, maintenance, and qualification of new processes/equipment.
Support revalidation of existing processes/equipment during planned shutdowns.
Develop staff training plans for new equipment and participate in supplier training courses.
Faults/Technical Support
Organize systems for fault management during validation.
Maintain maintenance logs and records of faults.
Provide technical expertise in troubleshooting and resolving equipment failures or process deviations.
Collaborate with production and quality teams for corrective actions and root-cause analysis.
Continuous Improvement
Drive process optimization initiatives to improve yield, efficiency, safety, and cost-effectiveness.
Identify opportunities for operational efficiencies, quality, and compliance improvements.
Lead or participate in continuous improvement projects (Lean, Six Sigma, Kaizen).
Quality Systems
Assist with the development, implementation, and management of cGMP and Quality Assurance systems.
Maintain training to support validation activities within the RPU.
Aseptic Training
Complete media fill training as necessary to support validation.
Chemicals
Ensure ordering, preparation, safe storage, and disposal of chemicals for validation projects.
Standard Operating Procedures (SOPs)
Prepare and update SOPs as necessary.
Training
Provide hands-on validation training for staff.
Undertake annual GMP, Pharmacovigilance, Radiation refresher training, and remain compliant with mandatory eLearning and AML policies.
R&D
Develop and introduce new products as required by the business.
Skills in Radiochemistry
Operate cyclotron, produce radioisotopes, synthesize radiolabelled PET radiopharmaceuticals, and follow clean room protocols.
Alliance Medical are Europe’s leading independent provider of imaging services.
We combine service excellence and innovative imaging technologies to improve patient care and support NHS and independent organisations with their ongoing imaging requirements. Our approach has delivered consistent company growth for more than 30 years.
We live by our company values to ensure the highest level of patient care:
Our Values
Leaders, managers, and supervisors have a particular responsibility to be role models in terms of how they demonstrate these values themselves and how they engage their teams to work in this way.
1. Collaboration: We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.
2. Excellence: We never compromise. We strive to deliver the very best in everything we do to ensure the highest quality of care. We treat our patients and each other with compassion, dignity, and respect.
3. Learning: Knowledge and understanding come from learning. At Alliance Medical, we are committed to ensuring that each and every one of us keeps on learning and that we continuously look for improved ways of working.
4. Efficiency: Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.
5. Openness: We act with transparency and honesty in everything we do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.
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