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Archived job description:

Job title:

Senior Radiopharmacist/Radiopharmaceutical Scientist Lead

Band: 7
Hours of work: 37.5 hours per week (flexible arrangement between 05:00 and 17:00)

Location: Division B – Imaging Department – Radiopharmacy – Nuclear Medicine Department

To whom responsible: Head of Radiopharmacy

Job summary:

• Working in an MHRA licensed aseptic production facility. In collaboration with the Production Manager, help plan and manage the production of radiopharmaceuticals. In collaboration with QA help develop and maintain the Pharmaceutical Quality System (PQS) compliant with EU GMP requirements as applicable to the manufacture of ‘Specials’ licensed medicines and IMP Radiopharmaceuticals.
• To help plan, organise and co-ordinate the provision of analytical and environmental monitoring services from contract laboratories.
• To help maintain a database of environmental monitoring results and produce monthly trend reports.
• To contribute to the annual programme of self-inspections of Radiopharmacy.
• To perform Quality Control testing of radiopharmaceutical preparations.
• In collaboration with the Production and QA Managers to maintain awareness of forthcoming changes to the requirements of EU GMP and to plan the implementation of all such changes.
• To participate in teaching and training including competency based training of staff and other trainees.

Key duties and responsibilities:
Gallium Service Delivery:

• To contribute to ensuring all Medicines Healthcare Regulatory Agency (MHRA) licensing, EA and Health & Safety requirements are met.
• In Collaboration with the QA manager carry out regular analysis and evaluation of environmental conditions, interpret and trend results, and initiate any necessary corrective action that includes basic micro-organism identification and liaise with the Quality Control laboratory for specific organism identification. Record, and help to investigate, out-of specification environmental monitoring results through the Deviation Management System.
• To ensure a safe system of equipment and staff testing to ensure Gallium radiopharmaceutical product quality. In collaboration with Production Manager and QA Manager liaise with the Hospital Works Department and outside contractors with regard to maintenance, re-calibration of equipment and repair of equipment or facilities within Radiopharmacy. That includes monitoring the process, product, equipment performance and physical environment in Radiopharmacy and immediately informs the Head of Radiopharmacy of any problems or unusual occurrences.
• Ensure validation of disinfection and cleaning processes. Oversee the validation of staff aseptic technique and transfer processes and to timely organise operator broth tests, sanitisation transfer validation tests etc. for staff working with gallium radiopharmaceuticals in Radiopharmacy at regular intervals in accordance with regulatory requirements or with set standards.
• To take on the role of QA when appropriate and when agreed with the QA manager: carrying out the routine checks and testing of radiopharmaceuticals, clinical and laboratory materials received, ‘named patient’ products and QC of molecular products.
• Ensure systems are in place to proactively identify failures and investigate complex problems that may be identified through routine trending and monitoring i.e. through deviation management and change control.
• Review updates to legislation, regulations and standards to assess the impact on quality systems and processes; propose and assist in implementing changes to maintain compliance.
• Line manage, and plan the activities of, the QA Assistant Technical Officer, ensuring effective management of general human resource issues including appraisal, sickness absence, and recruitment and selection. Ensure training and development needs are met.
• Carry out departmental risk assessments including radiation, COSHH and Manual Handling according to relevant health and safety legislation and Comply with the requirements of the Health and Safety at Work Act and COSHH.

Radiopharmaceutical Production:

• To undertake radiopharmaceutical dispensing and dispensing accuracy checking of medicines including clinical trial materials, unlicensed medicines and other “specials” i.e. ensure the appropriateness of unlicensed medicines in line with MHRA and NHS guidance, and maintain associated documentation and records.
• To maintain a high level of practical aseptic expertise in order to participate when required participating in dispensing rota and that includes preparation, supply and distribution of radiopharmaceuticals, tailor-made diagnostics and therapies.
• Communicate effectively with customers of the Radiopharmacy to provide the best possible service. This will include medical, technical, scientific and nursing staff within the Department, and external clients.
• Strictly observe confidentiality of all information concerning patients, and comply with procedures relating to the Data Protection Act.
• Represent the service to a high professional standard in conduct, manner and appearance.

Radiation Protection:

• Undertake all tasks in accordance with Trust and Departmental local policies and procedures including: Standard Operating Procedures for the Radiopharmacy; Local Rules under IRR99 and Employer’s Procedures under IRMER 2000.
• Participate in the packaging of radioactive materials and preparation of legal documents for the transport of radioactive material by road to all clients in accordance with written procedures.
• Dispose of used and expired radiopharmaceutical kits on a daily basis according to local radioactive waste disposal procedures.
• Participate and accurately record radioactive contamination monitoring within Radiopharmacy in accordance with local procedures and rules.
• If necessary assist in decontamination processes after an accidental spill involving a diagnostic radiopharmaceutical.
• Accurately and timely log the receipt, storage and transport of radiopharmaceuticals and non-active pharmaceuticals.
• Wear and use appropriate PPE and finger dose, TLD and radiation monitors when handling radioactive products.

Teaching, Training Research and Development:

• Participate in the teaching, training and supervision of non-Radiopharmacy staff in aseptic technique and the safe handling of gallium and other radiopharmaceuticals.
• Assist in any radiopharmaceutical research projects and clinical trials.
• To initiate or take part in product development to meet the needs of the Trust, University and other units served by the Radiopharmacy and Nuclear Medicine department.

Miscellaneous:

• To regularly update and ensure all documentation used in Radiopharmacy in relation to gallium radiopharmaceuticals are to the standards set out in the local procedures and rules, following the recommendations of current the Rules and Guidance for Pharmaceutical Manufacturers and Distributors and the Rules Governing Medicinal Products in the European

Community.

• To be present, where possible, during visits by any regulatory inspectors and to provide relevant information and documentation as required and to participate in departmental and Trust audits.
• To undergo the personal appraisal and personal development planning process annually, with appropriate review(s) throughout the year. As part of professional development, the post holder is expected to attend courses and meetings relevant to Radiopharmacy.
• After appropriate training, to conduct personal appraisal and personal development planning annually for designated staff.
• Perform other professional, management and administrative duties when required.
• All staff who have access to or transfer data are responsible for that data and must respect confidentiality and comply with the requirement of the Data Protection Act 1998, in line with the Trust policies.
• Perform other duties appropriate to the grade as assigned by the Head of Radiopharmacy or Production Manager.

Essential Criteria 
Qualifications

• Degree in appropriate science subject e.g. Master of Pharmacy degree, Chemistry or Microbiology
• Membership of a professional body e.g. GPhC or RSC
• Postgraduate qualification in an appropriate specialist subject (PTQA, STP) or equivalent level of experience

Experience

• Previous experience in an MHRA-licensed pharmaceutical or radiopharmaceutical facility
• Previous experience with gallium radiopharmaceutical production and quality control
• Sound understanding of GMP and QA processes
• Experience of undertaking internal and external GMP audits
• Project management experience, including involvement of multi-disciplinary teams
• Experience of formal documentation and report writing

Knowledge

• Specialist knowledge of gallium radiopharmaceuticals and their production and quality control
• Excellent knowledge and understanding of current Good Manufacturing Practice
• Well-developed problem solving skills
• Understanding of environmental monitoring techniques and data implications
• Sound knowledge of environmental micro-organisms
• Well-developed IT skills, knowledge of electronic quality management systems

Skills

• Well-developed manual dexterity and handling using personal protective equipment e.g. shielding devices and/or hazardous products
• Ability to visually examine and discriminate radiopharmaceutical products during inspections
• Ability to perform complex QA/QC protocols/tasks accurately and timely to define local procedures

This job description contains the principal duties only. There are a range of other duties implicit in carrying out the principal ones. The duties and responsibilities of the post will be reviewed on a regular basis with the post holder and are subject to change according to the Department's priorities. This job description may be subject to review, in consultation with the post-holder, in view of any organisational change. Thereafter the job description and duties will be reviewed with the post-holder on an annual basis

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