Job summary
The new Molecular Imaging Research Centre (MIRC) at Castle Hill Hospital is a purpose built centre housing a radiopharmacy, blood labelling suite, a GE GENtrace cyclotron and PET radiotracer synthesis facilities.
The unit will produce GMP standard radiopharmaceuticals for research and clinical use for patients in Hull. The unit is newly opened and will progress operations working under Section 10 exemption in the Radiopharmacy unit. The post holder will support operations and QC testing for radiopharmacy and participate in the qualification and validation processes in the PET unit.
The Molecular Imaging Research Centre (MIRC) offers a unique opportunity to be involved in local, national and international research. The cyclotron enables tailored diagnostics improving availability and patient outcomes.
We are looking for an experienced, highly motivated Quality Control Manager to join our small team. You must have strong attention to detail, great organisational and leadership skills and a passion for quality management as a whole. Experience of working within the pharmaceutical industry is a distinct advantage.
Main duties of the job
The post holder must be eligible to be named on the MHRA specials licence and will manage key areas of the facility, in order to deliver a safe and robust clinical and research service.
Experience and in depth knowledge in quality control procedures and techniques, final product release, implementation and management of a PQS, deviation and change management, CAPA, Quality risk management, quality auditing, staff management and analytical data analysis is essential.
The unit will be committed to training and research, experience of both is essential. The post holder is a key member of the operational team, working closely with scientific, medical and technical staff in a high pressure environment where accuracy and safety is crucial. Excellent interpersonal and communication skills are essential.
The work is varied and demanding with an emphasis on accuracy, reliability and adaptability, requiring a high level of manual dexterity and accuracy. The post holder must be able to prioritise demanding clinical and research workloads.
The unit will begin operation early in the day so a rota system will operate making flexibility essential.
Applications from job seekers who require current Skilled Worker Visa sponsorship to work in the UK are welcome and will be considered alongside all other applications. You can determine the likelihood of obtaining a Certificate of Sponsorship for the post by assessing your circumstances against criteria specified on the gov.uk website.
About us
The Humber Health Partnership is one of the largest acute and community Partnership arrangements in the NHS, seeing well over one million patients every year and managing a budget of over £1.3 billion.
Made up of two Trusts - Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) and Hull University Teaching Hospitals NHS Trust (HUTH) - our Partnership has significant ambitions and is committed to delivering world-class hospital and community services for the 1.65 million people we serve.
Together we employ nearly 20,000 staff. Our five main hospital sites are Diana, Princess of Wales Hospital, Scunthorpe General Hospital and Goole and District Hospital, for NLAG and Hull Royal Infirmary and Castle Hill Hospital for HUTH.
As Teaching Hospitals working with the Hull York Medical School, we both lead and contribute to research in many areas - biomedical research, primary care, palliative medicine, cardiovascular and respiratory medicine, vascular surgery, cancer surgery and oncology.
We believe that by developing a diverse, inclusive, innovative, skilled and caring workforce, we can deliver excellent care to our patients and a great future for our employees, our Partnership and our community.
Job description
Job responsibilities
For further details with regard to this vacancy opportunity, please see the attached Job Description and Person Specification.
Should we receive a high volume of applications the advert may be closed earlier than stated.
We welcome applications from candidates who require Skilled Worker Visa sponsorship to work in the UK, and these will be considered alongside all other applications in line with our commitment to equality and inclusion.
Applicants can determine their potential eligibility for a Certificate of Sponsorship by reviewing the Skilled Worker Visa criteria set out by UKVI on the gov.uk website.
Job description
Job responsibilities
For further details with regard to this vacancy opportunity, please see the attached Job Description and Person Specification.
Should we receive a high volume of applications the advert may be closed earlier than stated.
We welcome applications from candidates who require Skilled Worker Visa sponsorship to work in the UK, and these will be considered alongside all other applications in line with our commitment to equality and inclusion.
Applicants can determine their potential eligibility for a Certificate of Sponsorship by reviewing the Skilled Worker Visa criteria set out by UKVI on the gov.uk website.
Person Specification
Education/ Qualifications
Essential
- Degree in Chemistry, Pharmacy or a Biological Science.
- Post graduate qualification (MSc level) in a pharmaceutical science or chemistry subject or equivalent training and experience.
- Professional registration held with a recognised Healthcare Regulatory body-GPhC or HCPC or Royal Society of Chemistry, Biology or equivalent / In a position to apply.
- Evidence of continuing professional development.
Desirable
- Holds Qualified Person status on one of the statutory Registers of Eligible Qualified Persons or eligible to be nominated as QP under permanent provision 2001/83/EC.
- Trained as a radiation protection supervisor.
- Further qualification in leadership/management.
Knowledge, Training & Experience
Essential
- Knowledge and experience of using a wide range of Quality control laboratory testing equipment in a GMP compliant environment (raw materials and end product release testing)
- Acceptable experience for a Quality Controller as described within the MHRA Guidance for Specials Manufacturers (2022)
- Evidence of working within GMP/GLP guidelines and familiarity in GMP, QA, QC and quality risk management.
- Evidence of strategic planning/service development experience
- Staff management and training experience.
Desirable
- Experience in PET/radio pharmacy/aseptic services.
- Experience in HPLC method development.
- Experience in Clinical trial responsibilities.
- Experience of the recruitment process and of conducting appraisals.
- Experience of tendering for contracts.
- Experience in testing of analytical methods for new radiotracers.
- Knowledge of interpretation of stability data obtained from a range of sources
- Experience of working in a commercial licensed unit.
Communication and Interpersonal Skills
Essential
- Ability to evaluate critical steps in processes to optimise quality.
- Ability to concentrate and work under pressure
- To be able to implement change processes effectively
- To be able to perform Quality Assurance for the combined unit service.
- To be competent in QC procedures.
- Good communication skills both written and verbal.
- Effective skills in liaising with colleagues and other disciplines.
- Knowledge of principles and application of radiation protection and associated legislation
Desirable
- Radiation protection supervisor or suitability to undertake training.
- COSHH knowledge and application experience
- To be competent in all aspect of a radiopharmacy service delivery
- Leadership skills
- Audit skills
- Ability to write up and present projects and audits.
Special Attributes and other
Essential
- Shows motivation in developing new skills
- High level of interpersonal skills
- Demonstrate empathy and diplomacy
- Flexible and reliable
Other Requirements
Essential
- Ability to work under pressure
- I.T. skills.
- Self-motivated, with an ability to initiate and complete tasks.
Desirable
Person Specification
Education/ Qualifications
Essential
- Degree in Chemistry, Pharmacy or a Biological Science.
- Post graduate qualification (MSc level) in a pharmaceutical science or chemistry subject or equivalent training and experience.
- Professional registration held with a recognised Healthcare Regulatory body-GPhC or HCPC or Royal Society of Chemistry, Biology or equivalent / In a position to apply.
- Evidence of continuing professional development.
Desirable
- Holds Qualified Person status on one of the statutory Registers of Eligible Qualified Persons or eligible to be nominated as QP under permanent provision 2001/83/EC.
- Trained as a radiation protection supervisor.
- Further qualification in leadership/management.
Knowledge, Training & Experience
Essential
- Knowledge and experience of using a wide range of Quality control laboratory testing equipment in a GMP compliant environment (raw materials and end product release testing)
- Acceptable experience for a Quality Controller as described within the MHRA Guidance for Specials Manufacturers (2022)
- Evidence of working within GMP/GLP guidelines and familiarity in GMP, QA, QC and quality risk management.
- Evidence of strategic planning/service development experience
- Staff management and training experience.
Desirable
- Experience in PET/radio pharmacy/aseptic services.
- Experience in HPLC method development.
- Experience in Clinical trial responsibilities.
- Experience of the recruitment process and of conducting appraisals.
- Experience of tendering for contracts.
- Experience in testing of analytical methods for new radiotracers.
- Knowledge of interpretation of stability data obtained from a range of sources
- Experience of working in a commercial licensed unit.
Communication and Interpersonal Skills
Essential
- Ability to evaluate critical steps in processes to optimise quality.
- Ability to concentrate and work under pressure
- To be able to implement change processes effectively
- To be able to perform Quality Assurance for the combined unit service.
- To be competent in QC procedures.
- Good communication skills both written and verbal.
- Effective skills in liaising with colleagues and other disciplines.
- Knowledge of principles and application of radiation protection and associated legislation
Desirable
- Radiation protection supervisor or suitability to undertake training.
- COSHH knowledge and application experience
- To be competent in all aspect of a radiopharmacy service delivery
- Leadership skills
- Audit skills
- Ability to write up and present projects and audits.
Special Attributes and other
Essential
- Shows motivation in developing new skills
- High level of interpersonal skills
- Demonstrate empathy and diplomacy
- Flexible and reliable
Other Requirements
Essential
- Ability to work under pressure
- I.T. skills.
- Self-motivated, with an ability to initiate and complete tasks.
Desirable
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 (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).
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.
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).
