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 expected to open in April 2024 and prior to this, the post holder will participate in the qualification and validation processes involved during commissioning.
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. The unit has a small dedicated team, ready to commence facility operations in early 2024.
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 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
Hull University Teaching Hospitals is part of one of the largest acute and community Group 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 - Hull University Teaching Hospitals NHS Trust (HUTH) and Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) - our Group 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 Hull Royal Infirmary and Castle Hill Hospital for HUTH and Diana, Princess of Wales Hospital, Scunthorpe General Hospital and Goole and District Hospital, for NLaG.
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 Group and our community.
Should we receive a high volume of applications the advert may be closed earlier than stated. To view a full job description and person specification please see attachments on this advert.
Job description
Job responsibilities
To deputise for the Facility manager in their absence undertaking all managerial responsibilities associated with the role.
As the Quality Control Manager for the combined Radiopharmacy and Cyclotron Production Facility ensure departmental and Trust objectives are met.
Manage aspects of the Quality Management System for the facility and be responsible for its upkeep and development, culturing staff engagement and adherence.
Deliver a comprehensive service to the Trust Nuclear Medicine Department and other contracted parties.
Co-ordinate and develop all aspects of QA, Good Manufacturing Practice (GMP) and Quality Control (QC) within the unit ensuring that regulatory standards are met and current National guidance is adopted.
Assist in the exploration and development of research opportunities, engaging with Hull University Pre-clinical Radiochemist associates.
Play an active and influential role in improving processes and implementing change.
Job description
Job responsibilities
To deputise for the Facility manager in their absence undertaking all managerial responsibilities associated with the role.
As the Quality Control Manager for the combined Radiopharmacy and Cyclotron Production Facility ensure departmental and Trust objectives are met.
Manage aspects of the Quality Management System for the facility and be responsible for its upkeep and development, culturing staff engagement and adherence.
Deliver a comprehensive service to the Trust Nuclear Medicine Department and other contracted parties.
Co-ordinate and develop all aspects of QA, Good Manufacturing Practice (GMP) and Quality Control (QC) within the unit ensuring that regulatory standards are met and current National guidance is adopted.
Assist in the exploration and development of research opportunities, engaging with Hull University Pre-clinical Radiochemist associates.
Play an active and influential role in improving processes and implementing change.
Person Specification
Qualifications
Essential
- Degree level qualification in Chemistry, Pharmacy or a Biological Science
- Post graduate qualification in a pharmaceutical science or chemistry subject or equivalent training and experience
Desirable
- Trained as a Radiation protection officer
- Management qualification
Experience
Essential
- Relevant experience for a Quality Controller as described within the MHRA Guidance for Specials Manufacturers (2022)
- Experience of using and maintaining a wide range of quality control laboratory testing equipment
- Evidence of working within GMP/GLP guidelines and familiarity in GMP, QA, QC and quality risk management
Desirable
- Experience of PET and radiochromatic methods in a QC environment
- Experience in HPLC method development
- Experience in clinical trial responsibilities
Knowledge
Essential
- Knowledge of how a Pharmaceutical Quality Management system works in practice
- Experience and in depth knowledge in quality control procedures and techniques.
Desirable
- Knowledge of interpretation of stability data obtained from a range of sources
- Knowledge of IRR, IRMER and other relevant legislation
Skills
Essential
- Able to concentrate and work under pressure
- Competent in QC procedures
- Able to implement change processes effectively
- Leadership skills and proven experience
Desirable
- Able to interpret and document data to fulfil legislative requirements
- Audit skills
Other
Essential
- Must be self motivated, with an ability to initiate and complete tasks
- Have good communication skills, able to liaise with a range of stakeholders
Desirable
- Strong presentation skills
Person Specification
Qualifications
Essential
- Degree level qualification in Chemistry, Pharmacy or a Biological Science
- Post graduate qualification in a pharmaceutical science or chemistry subject or equivalent training and experience
Desirable
- Trained as a Radiation protection officer
- Management qualification
Experience
Essential
- Relevant experience for a Quality Controller as described within the MHRA Guidance for Specials Manufacturers (2022)
- Experience of using and maintaining a wide range of quality control laboratory testing equipment
- Evidence of working within GMP/GLP guidelines and familiarity in GMP, QA, QC and quality risk management
Desirable
- Experience of PET and radiochromatic methods in a QC environment
- Experience in HPLC method development
- Experience in clinical trial responsibilities
Knowledge
Essential
- Knowledge of how a Pharmaceutical Quality Management system works in practice
- Experience and in depth knowledge in quality control procedures and techniques.
Desirable
- Knowledge of interpretation of stability data obtained from a range of sources
- Knowledge of IRR, IRMER and other relevant legislation
Skills
Essential
- Able to concentrate and work under pressure
- Competent in QC procedures
- Able to implement change processes effectively
- Leadership skills and proven experience
Desirable
- Able to interpret and document data to fulfil legislative requirements
- Audit skills
Other
Essential
- Must be self motivated, with an ability to initiate and complete tasks
- Have good communication skills, able to liaise with a range of stakeholders
Desirable
- Strong presentation skills
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).
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.
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
Hull University Teaching Hospitals NHS Trust
Address
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital
Castle Road, Cottingham.
Hull
HU165JQ
Employer's website
https://www.hey.nhs.uk/ (Opens in a new tab)
