Operations Manager - Radiopharmacy Guildford, England
Job description
About This Role
A rare opportunity has arisen to join us as an operations manager at our Radiopharmaceutical production site in Guildford.
This role would be well suited to an individual who is a scientific graduate with a scientific background, ideally with experience of (radio) pharmaceutical manufacturing in a GMP environment.
You must be able to demonstrate leadership,have previous managerial experience and sound knowledge of PET-CT manufacturing processes is essential.
This is a full time role, working 40 hours per week.
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
Responsibilities
- Manage all aspects of production, testing and supply of Fluorine-18 (18F). Under a Rota system, undertake operation of cyclotron and production of Fluorine-18 (18F), and radio-synthesis of 18F radiopharmaceuticals for PET imaging (see job description of production Radiochemist).
- Manage operational activities for the manufacture of 18F for the production synthesis of standard 18FDG and other PET tracers in strict adherence to GMP and relevant EU pharmacopoeia standards.
- Manage routine protocols for the chemistry laboratory including the production of standard 18FDG synthesis and other PET tracers in strict adherence to GMP and relevant EU pharmacopoeia standards. Manage raw material sampling, testing and release system.
Staff
Establish and maintain rotas for staff for routine operational activities, maintenance and breakdowns.
Responsible for day to day supervision of staff to ensure manpower available to meet operational needs.
Training and development of staff to ensure staff perform their operational roles and to ensure ongoing personal development and best practice.
Maintenance
Establish and maintain detailed schedules of work required for all production and quality control equipment. Allocate work to staff and/or organise contractors to perform work.
Participate in supplier training courses to maintain and develop understanding of best practice.
Faults
Organise systems for management of faults and repairs as required. Ensure maintenance logs are maintained to aid troubleshooting, GMP requirements and for training of staff.
Interpret and rectify operational faults where possible and indicate where the engineer should be called.
Quality Systems
Develop, implement and manage cGMP, Quality Control and Quality Assurance systems and procedures for all aspects of production and quality control.
Principal Operator /
Timetable
As required, act as principal technician for all production and quality control equipment in accordance with pre-determined daily timetable.
Targetary
Responsible for developing and maintaining key performance indicator records for all aspects of production, quality control and distribution in accordance with GMP guidelines, safety and business needs.
Maintenance and Engineering Services
Manage appropriate maintenance/engineering arrangements to ensure reliable delivery of critical services including air handling, chilled water, gases, electric power and security.
Materials
Management of stocks including policies, monitoring, ordering and recording for routine radiochemistry production including formulation of reagents, etc and the safe disposal of waste chemicals and materials.
Management of stocks of spares and consumables for all production and quality control equipment. Set up systems for policy levels and ensure stocks are replaced following use.
Standard Operating Procedures
Prepare updated SOPs in accordance with the relevant guidelines as may be necessary from time to time for approval by the QP and adoption by the unit.
R & D
Search out, promote and manage R&D initiatives that both enhance the reputation of and their professional staffs as is consistent within approved budgets and grants.
Skills in Radiochemistry
Develop necessary skills to provide relief and rota support to radiochemical laboratory technician/s with specific reference to the functions of:
§ Operation of cyclotron.
§ Production of Radioisotopes
§ QC analytical testing
Safety and Control
Assume responsibility for the safe and efficient handling of all radioactive substances (solid, gas, liquid) received from the Centre’s cyclotron including their synthesis, transmission, dispensing, storage, containerisation, packing, despatch, transport, decay control, and release. In accordance with local rules for emergency or serious incident procedure record such events in accordance with SOPs.
Responsible for management of agreed safety procedures to ensure safety of yourself and others.
Regulatory
Strictly adhere to GMP, GLP and safety protocols laid down by the MHRA, EA and HSE in accordance with issued licenses as determined from time to time. Corresponding adherence to Local Rules developed by Erigal in conformity to such licensing requirement.
Alliance Medical Values
Alliance Medical 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.
Collaboration:
We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.
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.
Learning:
Knowledge and understanding comes 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.
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.
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.
