Radiopharmacy Production Manager

Job overview

We are offering an exciting opportunity for an enthusiastic, self-motivated and highly skilled individual to join our Nuclear Medicine team as a Radiopharmacy Production Manager delivering the Nuclear Medicine service at University Hospitals Plymouth NHS Trust.

The post holder will be responsible for the management of the Radiopharmacy production unit. This is a complex service which provides an essential daily supply of aseptic radiopharmaceuticals prepared in compliance with EU Good Manufacturing Practice and licensed by the Medicines and Healthcare products Regulatory Agency (MHRA).

The postholder will also ensure provision of technical and professional support and expertise in all aspects of preparation of radiopharmaceuticals to clinicians and other professionals within Plymouth Hospitals NHS Trust.

The post holder is named as Production Manager in the Manufacturer’s “Specials” Licence as granted by the Medicine and Healthcare Products Regulatory Agency (MHRA).  And oversees the provision of technetium-99m radiopharmaceuticals to neighbouring Nuclear Medicine departments on an as and when basis.

***Preference will be given to internal Trust staff, as well as ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***

Main duties of the job

Responsibility for daily management and control of production systems including dealing with immediate production queries to ensure that required standards are maintained.

Responsible for ensuring the application of specialist technical knowledge to ensure the development and maintenance of the Radiopharmacy systems of safe working practice to include scheduling of work, preparation, service continuity, review and auditing of work instructions and other documents, quality monitoring, investigating complaints and reporting to management in accordance with procedures.

Responsible for generation and review of Standard Operating Procedures and other documentation critical to the delivery of the service. In conjunction with the Radiopharmacy Quality Manager development and maintenance of data systems.

Plans the operational development of the Radiopharmacy service in association with the Radiopharmacy Quality Manager and ensures that services meet the needs of the Trust and optimise the use of assets. Contributes, where appropriate, to service level agreements and capacity planning for the department.

Interprets guidance issued by EU and UK legislative authorities. Ensures compliance with the Medicines Act 1968, EU regulations including 2001/83/EC, 2003/94/EC and standard provisions for Manufacturer’s Specials Licence and all other relevant provisions where they apply to licenced activity.

Detailed job description and main responsibilities

• Manages the production of the Radiopharmacy Unit – provision of a complex service providing an essential daily supply of aseptic radiopharmaceuticals prepared in compliance with EU Good Manufacturing Practice and licenced by the Medicines and Healthcare Products Regulatory Agency.
• Named as Production Manager in the Manufacturer’s “Specials” Licence as granted by the Medicine and Healthcare Products Regulatory Agency (MHRA). Represents the Unit with the Radiopharmacy Quality Manager during external inspections by the MHRA Medicines Inspectorate and other external agencies and communicates with these bodies as necessary.
• Provides technical and professional support and expertise in all aspects of preparation of radiopharmaceuticals to clinicians and other professionals within Plymouth Hospitals NHS Trust. Establishes and maintains strategic links with a range of internal and external partners.
• Responsibility for daily management and control of production systems including dealing with immediate production queries to ensure that required standards are maintained. Responsible for ensuring the application of specialist technical knowledge to ensure the development and maintenance of the Radiopharmacy systems of safe working practice to include scheduling of work, preparation, service continuity, review and auditing of work instructions and other documents, quality monitoring, investigating complaints and reporting to management in accordance with procedures.
• Responsible for generation and review of Standard Operating Procedures and other documentation critical to the delivery of the service. In conjunction with the Radiopharmacy Quality Manager development and maintenance of data systems.

For further information please see attached job description