Job summary
We are looking for a pharmacist / scientist to join our radiopharmacy team. The successful candidate will provide specialised GMP and quality assurance services within the Radiopharmacy manufacturing service for established and novel SPECT and PET radiopharmaceuticals.
You must have advanced knowledge and experience working within an aseptic environment and advanced knowledge of cleanrooms and associated equipment, Pharmaceutical Quality Management Systems and the requirements of Good Manufacturing Practice. You must haveexpertise and practical knowledge in Quality assurance and Quality Management.
You must be highly organised with excellent communication and interpersonal skills and have the ability to lead and motivate staff as well as collaborate with others. You should have a flexible 'hands on' approach to routine work, able to multi-task, possess creative problem solving skills and the motivation to adopt and drive change. You will also assist in training, education and research activities including involvement in clinical trials.
This post will provide the opportunity to apply and build upon existing experience in aseptic services, and lead on projects / new products / service aspects. Experience in the production of radiopharmaceuticals and working in a MHRA licensed manufacturing facility would be beneficial.Registration within a regulated profession is required as per Personal Specification.
Main duties of the job
To support maintaining, monitoring and developing quality assurance and general day to day supervision and aspects of the provision and delivery of the Radiopharmacy service.
To maintain the Pharmaceutical Quality System of the Radiopharmacy service which is a requirement of EU Good Manufacturing Practice and the Manufacturer's "Specials" Licence issued by the Medicinesand Healthcare products Regulatory Agency (MHRA).
To act as an authorised releasing officer for radiopharmaceuticals
To carry out production and quality control duties fordiagnostic and therapeutic radiopharmaceuticals.
To develop, implement and follow measures and systems for maintaining compliance with quality assurance, relevant legislation, guidelines, protocols and SOPs.
To be designated by the Trust as an operator under the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) and as a Classified Worker under the Ionising Radiations Regulations (IRR).
About us
The Radiopharmacy unit is situated within the Nuclear Medicine department, supplying a range of diagnostic and therapeutic radiopharmaceuticals, under MHRA Licences. We are actively involved in a number of clinical trials and are one of the few UK hospitals to provide a Ga-68 peptide service.
The post-holder will be a key member of a team of pharmacists, scientists and technicians, and part of a wider Nuclear medicine department team of clinicians, physicists, nuclear medicine technologists, administration and clerical staff. You will also work with nursing staff, academic andcommercial organisations.
Job description
Job responsibilities
To support maintaining, monitoring and developing quality assurance and general day to day supervision and aspects of the provision and delivery of the Radiopharmacy service.
To maintain the Pharmaceutical Quality System of the Radiopharmacy service which is a requirement of EU Good Manufacturing Practice and the Manufacturers Specials Licence issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
To act as an authorised releasing officer for radiopharmaceuticals
To carry out aseptic production and quality control duties for of diagnostic and therapeutic radiopharmaceuticals.
To develop, implement and follow measures and systems for maintaining compliance with quality assurance, relevant legislation, guidelines, protocols and SOPs.
To be designated by the Trust as an operator under the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) and as a Classified Worker under the Ionising Radiations Regulations (IRR
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Professional registration as a Pharmacist with the General Pharmaceutical Council (GPhC) or as a Clinical Scientist with the Healthcare Professional Council (HCPC).
- Post-graduate qualification (MSc level) in Radiopharmacy or equivalent knowledge & expertise in the field
- IR(ME)R training record
Desirable
- Holds Qualified Person status on one of the statutory Registers of Eligible Qualified Persons
- Membership of an appropriate professional body (Royal Pharmaceutical Society of GB, Royal Society of Chemistry, Institute of Physics and Engineering in Medicine).
- European Association of Nuclear Medicine Postgraduate Certificate in Radiopharmacy / Diploma in Pharmaceutical Technology & Quality Assurance or equivalent knowledge & expertise in the field
- Professional knowledge acquired through first degree in a pharmacy or chemistry-related discipline.
Experience
Essential
- Significant operational experience working within a conventional Radiopharmacy, to include at least 2 years recent experience at Band 7 or equivalent
- Experience of aseptic preparation of radiopharmaceuticals using isolators in a licensed GMP facility.
- Experience of specification and monitoring of environment / equipment / products relevant to radiopharmacy.
- Experience of maintaining a Quality Management System, including change control, investigation of errors and deviations.
- Experience of managing staff.
- Experience of personal career involvement in operational management of radiopharmacy service provision
- Experience in supporting new service development
- Experience in writing reports and Standard Operating Procedure for new processes or new equipment.
Desirable
- Experience in the manufacturing and quality testing of 68Ga radiopharmaceuticals using manual and automated synthesis system methods for clinical use.
- Experience of involvement in clinical trial related activities.
- Experience as authorised releasing officer for radiopharmaceuticals.
- Experience in budget management
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website .
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants .
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website .
Employer details
Employer name
Royal Free London NHS Foundation Trust
Address
Royal Free Hospital
London
NW3 2QG