QA Officer Radiopharmacy

As QA Officer you will help ensure the Radiopharmacy complies with all relevant regulations. You will continue to develop the Radiopharmacy clinical expertise and assist with the implementation of new technologies and the introduction of preparation and clinical application of new products.,

• Release of products manufactured in the Specials licensed unit.
• Assist in maintaining the Radiopharmacy Pharmaceutical Quality System under the guidance of the Senior QA Officer.
• Support the Senior QA Officer in performing quality control testing of products manufactured in the Specials licensed unit.
• Contribute to the ongoing development and maintenance of the Radiopharmacy training program.
• Assist the Senior QA Officers and Lead QA in ensuring that the department complies with Good Manufacturing Practice (GMP) as defined by the Medicines and Healthcare products Regulatory Agency (MHRA).
• + Assist in providing routine radiopharmacy services, including the provision and quality testing of diagnostic, therapeutic, and theragnostic radiopharmaceuticals. + Support the provision of a complex radiolabelling service, including the radiolabelling of peptides for therapeutic applications. + Act as a Radiopharmacy Operator as defined by the Ionising Radiations (Medical Exposure) Regulations 2017. + Liaise with radiopharmaceutical manufacturers to ensure the quality and continuity of service provision. + Provide advice to end users on the safe and effective use of radioactive medicinal products, including storage conditions, formulation, and potential adverse reactions. + Assist in the evaluation and validation of equipment and software for use in the Radiopharmacy.,
• The post-holder will be responsible for performing release of products manufactured in the Specials licensed unit.
• The post-holder will be jointly responsible for performing quality control testing of products manufactured in the Specials licensed unit.
• The post-holder will be responsible for ongoing development and maintenance of the Radiopharmacy training program, as part of the overall Radiopharmacy Pharmaceutical Quality System.
• The post-holder will contribute to ensuring that the department complies with the requirements for Good Manufacturing Practice, as defined in The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Medicines and Healthcare products Regulatory Agency).
• The post-holder will contribute to the provision of the routine Radiopharmacy service, including provision of diagnostic, therapeutic and theragnostic radiopharmaceuticals (including quality testing of these products) and provision of a range of in vitro tests.
• The post-holder will, jointly with other suitably qualified staff, provide a complex radiolabelling service (including radiolabelling of peptides for therapeutic applications).
• The post-holder will be required to act as a Radiopharmacy Operator, as defined by the Ionising Radiations (Medical Exposure) Regulations, 2017.
• The post-holder will be required to liaise with radiopharmaceutical manufacturers to ensure a quality of suitable radiopharmaceutical products to deliver continuity of service provision.
• The post-holder will be expected to provide advice to end users of issues relating to the safe and effective use of radioactive medicinal products, including storage conditions, formulation and potential adverse reactions.
• The post-holder will assist in the evaluation and validation of equipment and software for use in the Radiopharmacy., The Trust is committed to promoting a healthy work-life balance and achieve fair, equitable and consistent practice. We welcome flexible working requests and will consider a variety of flexible working arrangements from day one of your employment. Not all roles are suitable for every flexible working opportunity all of the time. Flexible working options may include reduced hours, compressed hours, fixed shifts, time back in lieu and home working.
The Trust is committed to promoting equality and diversity; we value the contribution of individual talent, skills, knowledge and experience and aim for a workforce demography representative of the local community. We encourage applicants from the following groups that are currently under-represented in our workforce black, Asian and minority ethnic, lesbian, gay, bisexual and Transgender (LGBTQ+), disabled, male and age 16-24. Trust policy requires that the cost of submitting & processing the successful applicant/s DBS application be recovered via salary deduction following start in post. The amount of £23 (standard disclosure) or £43 (enhanced disclosure) will be deducted from salary, in manageable monthly instalments for up to 3 months following commencement of employment. Bank posts require upfront payment. DBS applications submitted from 2nd December will be subject to the new DBS fee of £26.50 (standard) and £54.50 (Enhanced). From April 2017, Skilled visa applicants and their adult dependant(s) will be required to provide a criminal record certificate from each country they have lived in consecutively for 12 months or more in the past ten years. Applicants requiring sponsorship may wish to determine the likelihood of obtaining sponsorship for this position by assessing themselves against the criteria on the gov.uk website - https://www.gov.uk/check-uk-visa. This organisation has a zero-tolerance approach to the abuse of children, young people and vulnerable adults. All staff must ensure they adhere to the organisations safeguarding children and adults' policy and comply with the Local Safeguarding Children and Adult Board procedures. Staff should be mindful of their responsibility to safeguard children and adults in any activity performed on behalf of the organisation in line with the requirements of statutory guidance and legislation. All employees (and volunteers)are expected maintain their safeguarding knowledge and skills by completing mandatory safeguarding training which includes understanding and recognising the signs of abuse and neglect and taking appropriate action. As an organisation, we have adopted the Merseyside Domestic abuse workplace scheme which supports our staff who are experiencing Domestic Abuse /any forms of sexual violence.

We are seeking a dynamic individual with experience of working in radiopharmacy and/or technical services. Experience of working in Quality Assurance or a GMP-controlled environment is desirable.,
• Master Degree in Pharmacy or equivalent
• Registered with relevant body, Post-graduated MSc/Diploma in Pharmaceutical Technology and Quality Assurance or equivalent experience.
• KCL Radiopharmacy course or equivalent
• KCL Advanced Radiopharmacy course or equivalent
• Radiation Protection Supervisor (RPS), Experience of working in Radiopharmacy or MS special licence units at least 5 years for BTEC or NVQ Level 3
Desirable criteria
• Experience of working in Radiopharmacy or Aseptic S10 or MS special licence units in QA role
• Experience as releasing officer in MHRA "Specials" Unit
• Experience in Education and Training within GMP and Radiopharmacy environment
• Experience in validation of equipment
• Experience in validation of processes
• Experience in project management and service development, Good practical knowledge of Good Manufacturing Practice (GMP) regulations, Good practical knowledge of IRR17
• Good practical knowledge or IR(ME)R 2017 regulation
• Good practical knowledge of Good Clinical Practice (GCP) regulation
• Good practical knowledge of Radiopharmacy preparation, Good verbal skills
• Good written communication skills
• Logical thought processes
• Ability to work under pressure
• Ability to prioritise appropriately
• Ability to work as a part of a team
• Problem solving and decision making
• Good IT skills - ability to use Word, Excel, PowerPoint, and ability to learn new computer software used in Radiopharmacy, Evidence of continuing professional development and of acquiring new skills.
• Demonstrate commitment to the development of others, You must have appropriate UK professional registration.
  
  This is an exciting opportunity for a highly driven individual to participate in the development and delivery of the Radiopharmacy quality and clinical service from our state-of-the- art facility at Royal Liverpool University Hospital.
The post-holder will be undertake quality assurance and quality control activities within the department as part of the Quality Assurance team. The Radiopharmacy at LUHFT is designed to deliver wide range of radiopharmaceuticals for imaging, therapy and investigational medicinal products for clinical trials as well as blood labelling suite., Liverpool University Hospitals NHS Foundation Trust comprises Aintree University Hospital, Broadgreen Hospital & Royal Liverpool University Hospital. We are part of NHS University Hospitals of Liverpool Group, formed on 1 Nov 2024 from the coming together of LUHFT and Liverpool Women's NHS Foundation Trust. The Group was born from a shared aim to improve the care we provide our patients. UHLG is one of the largest employers in the region, with over 16,800 colleagues dedicated to caring for our communities - from birth and beyond. For the 630,000 people across Merseyside, we are their local NHS. We provide general and emergency hospital care, alongside highly specialised regional services for more than two million people in the North West. Aintree University Hospital is the single receiving site for adult major trauma patients in Cheshire and Merseyside and hosts a number of regional services including an award-winning stroke facility. Broadgreen Hospital is home to elective surgical, diagnostic and treatment services, together with specialist patient rehabilitation. Liverpool Women's Hospital specialises in the health of women and babies, delivering over 7,200 babies in the UK's largest single site maternity hospital each year. The Royal Liverpool University Hospital is the largest hospital in the country to provide inpatients with 100% single bedrooms and focuses on complex planned care and specialist services., The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.