QA Officer Radiopharmacy

Liverpool University Hospitals NHS Foundation Trust

Information:

This job is now closed

Job summary

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.

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.

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.

Please note that the vacancy may close early if a suitable amount of applications are received.

Main duties of the job

  • 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.

About us

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.

For roles at Liverpool Women's, visit their careers page.

Date posted

02 December 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,148 to £52,809 a year per annum

Contract

Permanent

Working pattern

Full-time

Reference number

287-DSS-515-24

Job locations

Royal Liverpool Hospital

Prescot Street

Liverpool

L7 8XP


Job description

Job responsibilities

  • 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.

Job description

Job responsibilities

  • 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.

Person Specification

Qualifications

Essential

  • Master Degree in Pharmacy or equivalent
  • Registered with relevant body

Desirable

  • 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

Essential

  • Experience of working in Radiopharmacy or MS special licence units at least 5 years for BTEC or NVQ Level 3

Desirable

  • 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

Knowledge

Essential

  • Good practical knowledge of Good Manufacturing Practice (GMP) regulations

Desirable

  • 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

Skills

Essential

  • 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

Other

Essential

  • Evidence of continuing professional development and of acquiring new skills.
  • Demonstrate commitment to the development of others
Person Specification

Qualifications

Essential

  • Master Degree in Pharmacy or equivalent
  • Registered with relevant body

Desirable

  • 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

Essential

  • Experience of working in Radiopharmacy or MS special licence units at least 5 years for BTEC or NVQ Level 3

Desirable

  • 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

Knowledge

Essential

  • Good practical knowledge of Good Manufacturing Practice (GMP) regulations

Desirable

  • 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

Skills

Essential

  • 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

Other

Essential

  • Evidence of continuing professional development and of acquiring new skills.
  • Demonstrate commitment to the development of others

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.

Certificate of Sponsorship

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 (Opens in a new tab).

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 (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Additional information

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.

Certificate of Sponsorship

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 (Opens in a new tab).

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 (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Liverpool University Hospitals NHS Foundation Trust

Address

Royal Liverpool Hospital

Prescot Street

Liverpool

L7 8XP


Employer's website

https://www.liverpoolft.nhs.uk/ (Opens in a new tab)


Employer details

Employer name

Liverpool University Hospitals NHS Foundation Trust

Address

Royal Liverpool Hospital

Prescot Street

Liverpool

L7 8XP


Employer's website

https://www.liverpoolft.nhs.uk/ (Opens in a new tab)


For questions about the job, contact:

QA Lead for Radiopharmacy

Megan Longworth

megan.longworth@liverpoolft.nhs.uk

01517064596

Date posted

02 December 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,148 to £52,809 a year per annum

Contract

Permanent

Working pattern

Full-time

Reference number

287-DSS-515-24

Job locations

Royal Liverpool Hospital

Prescot Street

Liverpool

L7 8XP


Supporting documents

Privacy notice

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