About the Role
This is an exciting opportunity for a Radiopharmaceutical Production Unit (RPU) Site Manager to join our team at Alliance Medical Diagnostic Imaging Ltd. in Ireland.
The RPU will manufacture and distribute radiopharmaceutical products that meet industry-leading standards in quality, efficacy, and innovation.
Overall Role:
* Work with Alliance Medical Radiopharma, the design and build team in the establishment of a fit-for-purpose RPU capable of meeting required production requirements.
* Design, develop, and operationalize all aspects of the RPU in line with all process and governance requirements and in line with regulatory compliance.
* Manage all aspects of production and supply of radiopharmaceutical products and be involved in future development & production of new radiopharmaceutical products.
* Ensure sufficient trained staff are available for the operation of cyclotron and production of radiopharmaceuticals.
* Take responsibility for the RPU P&L.
* Liaise with customers and suppliers as necessary to develop the business.
* Ensure the site is adhering to current Good Manufacturing Practices (cGMP).
Duties and Responsibilities
Production
* Manage operational activities for the manufacture of radiopharmaceutical products for the production synthesis of PET imaging products in strict adherence to GMP and relevant pharmacopoeia standards, ensuring high degree of supply reliability.
* Ensure the management of raw material purchasing sampling testing release system are maintained in line with production requirements.
* Responsible for the management of productive and streamlined processes ensuring that KPIs are met in line with RPU objectives.
* Ensure that all customers receive a highly reliable efficient seamless and high-quality service throughout the entire screening pathway.
* Ensure uptime of plant production equipment.
* Responsible for developing and maintaining key performance indicator records for all aspects of production and distribution in accordance with GMP guidelines safety and business needs.
* Work with the QA team to co-ordinate execute validation of GMP equipment and new product development.
* Participate in the preparation updating of Standard operating Procedures SOPs and Health Safety H&S 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.
Staff
* Responsible for the management of an engaged motivated RPU team effectively utilizing internal resources and supports including induction buddy system performance management delegation career development One-to-ones training.
* Establish maintain rotas for staff for all operational activities absence sickness holidays overtime out-of-hours working maintenance breakdowns.
* Liaise with the Production Manager Quality Control QC Engineering Managers and be responsible for day-to-day supervision of staff to ensure manpower available to meet operational needs.
* Training development including continued professional development of staff to ensure staff perform their operational roles and to ensure ongoing personal development best practice and ensure training records are maintained.
* Assist in developing implementing standard operating procedures and training plans for the team.
GMP Equipment Maintenance and Faults
* Ensure detailed schedules of work are established maintained for all production equipment.
* Allocate work to staff organize contractors to perform work.
* Participate in supplier training courses to maintain develop understanding of best practice.
* Ensure management of stocks spares consumables for cyclotron production quality control equipment.
* Organize systems for management of faults repairs as required.
* Ensure maintenance logs are maintained to aid troubleshooting GMP requirements training of staff.
* Maintain stocks critical spares for the facility.
Quality Systems
* Work with the Head of Quality to assist with the development implementation management of cGMP Quality Assurance systems procedures for all aspects of radiopharmaceutical production.
* Ensure compliance with radiation safety procedures guidelines.
* Work collaboratively with the Head of Quality to ensure full compliance with Quality Management Systems QMS.
* Strictly adhere to GMP Good Laboratory Practice GLP safety protocols laid down by the HPRA EPA Health Safety Authority in accordance with issued licenses as determined from time to time.
* Ensure appropriate management of maintenance engineering arrangements for reliable delivery of critical services air handling chilled water gases electric power security ensure high degree of uptime.
Production & QC Raw Materials Consumables
* Ensure appropriate management of stocks including policies monitoring ordering recording for routine radiochemistry production formulation reagents etc safe disposal of waste chemicals materials.
* Set up systems policy levels ensure stocks replaced following use.
Skills in Radiochemistry
* If qualified develop necessary skills provide relief rota support to production Radiochemist specific reference functions operation of cyclotron produce radioisotopes manufacture radiopharmaceutical tracers dispensing aseptic products.
Safety Control Security
* Assume responsibility safe efficient handling all radioactive substances solid gas liquid received from the site's cyclotron including synthesis transmission dispensing storage containerisation packing despatch transport decay control release in accordance with local rules emergency or serious incident procedure record such events SOPs.
* Responsible management agreed safety procedures ensure safety yourself others.
* Responsible ensuring day-to-day site compliance Security Plan assist required activities site emergencies planned exercises.
Management
* Produce detailed monthly reports financial operational metrics board of Alliance Medical Radiopharmacy Limited AMRL.
* Produce timely annual budgets AMRL.
* Advocate on behalf of AMRL customer groups throughout Ireland.
Qualifications
* Degree higher relevant scientific clinical engineering area equivalent experience.
* Background manufacture radiopharmaceuticals desirable.
* Previous managerial supervisory experience demonstrable track record strong performance.
* Experience successful customer relationships.
* Experience Quality Control radiopharmaceutical setting desirable.
* Demonstrated ability close working relationships internal external stakeholders extensive experience influencing decision making ownership initiatives.
Skills
* Excellent interpersonal organization skills.
* Flexible willingness actively involved all elements role.
* Leads example.
* Highly self-motivated.
* Able work own proactive defining executing tasks.
* Technical aptitude.