Job summary
The post holder will lead and manage the regional QA team to deliver the QA service to the East of England region. This includes:
- Provision of quality assurance expertise and support to the procurement, preparation and manufacture of medicines and medicines provider service to the NHS.
- Leading the programme of audit of NHS aseptic units across the region and provide support and oversight of high risk units through a programme of compliance management.
- Developing web-based best practice resources for the quality assurance of medicines in the NHS and support implementation through audit, training, mentoring and advice.
- Taking a lead across organisations in the development and implementation of quality risk management systems to underpin the principles of medicines optimisation and ensure consistently effective outcomes for patients.
- Promoting innovation and transformation in the NHS by taking a lead in development, implementation, and safe use of new medicines (e.g. clinical trials, ATMP, biological medicines) and technologies through working with regulators, academia and industry.
- Formulating, directing and delivering strategic plans for the provision of QA services to the NHS Trusts in the region. To support the region's Chief Pharmacist network and Regional Chief Pharmacist in delivering agreed work plans.
- Contributing to the development, implementation and delivery of the NHSE, SPS and NHS Pharmaceutical QA Committee work plans.
Main duties of the job
The Specialist Pharmacy Service (SPS) National Quality Assurance (QA) Service is an expert advisory service that supports the principles of medicines optimisation by the development and championing of best practice and by ensuring continuous improvement through the implementation of quality risk management systems in NHS medicines manufacturing & preparation and NHS supply chain management.
The SPS QA Function provides specialist advice relating to the quality of medicines to NHS pharmacy professionals to support safe patient care.The scope of our advisory and consultancy service includes:
- Aseptic preparation of medicines
- Manufacturing of unlicenced medicines
- Assigning shelf life to medicines
- Temperature controlled storage and distribution of medicines
- Assessing the pharmaceutical quality of medicines
The types of advisory and resources we provide include:
- Responses to queries and requests for help
- SPS articles
- Multi-media resources
- Exemplar procedures and templates
- Risk management materials for assessment of medicines
- Injectable medicines stability tool
- Audit reports
- Focused support to regional projects and NHS Trusts
- Participation in regional and national pharmacy networks and staff development events.
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.
Job description
Job responsibilities
Providing highly complex specialist QA advice and support to the NHS Organisations and networks on a range of specialist topics.
Lead and contribute to the development of articles for the SPS website relating to the quality assurance of medicines.
To develop and participate in webinars and podcasts to educate and promote best practice
To work and liaise with regulators and expert advisory groups (MHRA, BP, CHM, EAHP, RPS, GPhC) in the development and implementation of quality assurance standards for medicines.
To support local and regional service development and innovation, showcasing best practice.
To respond to relevant UK and EU medicines consultations on behalf of SPS, Regional Chief Pharmacists and regional networks.
For full details, please refer to the attached job description and person specification
Job description
Job responsibilities
Providing highly complex specialist QA advice and support to the NHS Organisations and networks on a range of specialist topics.
Lead and contribute to the development of articles for the SPS website relating to the quality assurance of medicines.
To develop and participate in webinars and podcasts to educate and promote best practice
To work and liaise with regulators and expert advisory groups (MHRA, BP, CHM, EAHP, RPS, GPhC) in the development and implementation of quality assurance standards for medicines.
To support local and regional service development and innovation, showcasing best practice.
To respond to relevant UK and EU medicines consultations on behalf of SPS, Regional Chief Pharmacists and regional networks.
For full details, please refer to the attached job description and person specification
Person Specification
Qualifications
Essential
- Degree in Pharmacy
- Registered with General Pharmaceutical Council
- Further qualification (MSC) within Pharmaceutical Technology or QA
Desirable
- Medical Gas testing (Quality Controller MPGS)
- Qualification in management
Experience
Essential
- Extensive post registration experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
- Significant experience of quality control testing of pharmaceuticals (chemistry and microbiology methods)
- Significant experience of risk management and quality management systems and their application
- Significant experience of auditing and self-inspection and report writing to meet pharmaceutical regulatory requirements
- Significant experience of planning and delivery of training (large and small groups) to more junior and also peer groups
- Significant experience of multidisciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
- Significant experience and evidence of successful development and implementation of policies and procedures to satisfy regulatory requirements
- Significant experience of working in both regional and national networks
- Significant experience of working with regulatory authorities
- Experience in all areas of NHS hospital pharmacy services including dispensary, clinical services and storage & distribution
Desirable
- Experience of working in Radiopharmacy services
- Experience of working with clinical trials
- Experience of quality control testing of medical gases
- Experience of procurement of medicines and product assessment
Knowledge
Essential
- Highly developed specialist knowledge of the regulatory and NHS standards and guidance relating to medicines manufacture and preparation
- Highly developed specialist knowledge of the regulatory and NHS standards and guidance relating to safe storage and supply of medicines
- Highly developed knowledge of the regulatory and NHS standards and guidance relating to medicines procurement and supply including homecare services
- Highly developed knowledge of pharmaceutics, medicine formulation and drug stability
- Good general and current knowledge of NHS developments and strategies relevant to medicines quality including primary and secondary care
- Specialist knowledge of clean room design, technology and operation for pharmaceutical processing
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
- Thorough understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
- Comprehensive understanding of pharmacy law and regulations n relation to manufacture, preparation and supply of medicines, including clinical trials
Desirable
- Good knowledge of ATMPs
- Awareness of national pharmaceutical contracting strategies including outsourced medicine compounding and homecare services
- Understanding of health and safety legislation as applicable to medicines manufacture and preparation
Skills
Essential
- Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or when dealing with uncertainty to inform professional judgement
- Excellent presentation and facilitation skills within small groups, large workshops and virtual audiences
- Self-motivated with excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities. Ability to work effectively on own and as part of a multidisciplinary team
- Excellent investigational and analytical skills with an ability to provide advice in highly complex situations
- Excellent interpersonal skills. Diplomatic, consultative and able to build consensus to successfully gain agreement and commitment with peers and customers Able to cope with conflict and handle difficult situations with a calm disposition
- Demonstrates tact, empathy and diplomacy when communicating confidential sensitive or contentious information
- Demonstrates leadership management negotiation, influencing and motivational skills to facilitate working across healthcare systems
- Ability to coach and mentor others
- Good IT skills ability to accurately produce documentation and presentations using Microsoft packages
Other
Essential
- Able to change into the appropriate clothing and spend time in pharmaceutical clean rooms and clinical areas
- Able to travel to anywhere in the East of England
Desirable
- Facility for remote/home working
Person Specification
Qualifications
Essential
- Degree in Pharmacy
- Registered with General Pharmaceutical Council
- Further qualification (MSC) within Pharmaceutical Technology or QA
Desirable
- Medical Gas testing (Quality Controller MPGS)
- Qualification in management
Experience
Essential
- Extensive post registration experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
- Significant experience of quality control testing of pharmaceuticals (chemistry and microbiology methods)
- Significant experience of risk management and quality management systems and their application
- Significant experience of auditing and self-inspection and report writing to meet pharmaceutical regulatory requirements
- Significant experience of planning and delivery of training (large and small groups) to more junior and also peer groups
- Significant experience of multidisciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
- Significant experience and evidence of successful development and implementation of policies and procedures to satisfy regulatory requirements
- Significant experience of working in both regional and national networks
- Significant experience of working with regulatory authorities
- Experience in all areas of NHS hospital pharmacy services including dispensary, clinical services and storage & distribution
Desirable
- Experience of working in Radiopharmacy services
- Experience of working with clinical trials
- Experience of quality control testing of medical gases
- Experience of procurement of medicines and product assessment
Knowledge
Essential
- Highly developed specialist knowledge of the regulatory and NHS standards and guidance relating to medicines manufacture and preparation
- Highly developed specialist knowledge of the regulatory and NHS standards and guidance relating to safe storage and supply of medicines
- Highly developed knowledge of the regulatory and NHS standards and guidance relating to medicines procurement and supply including homecare services
- Highly developed knowledge of pharmaceutics, medicine formulation and drug stability
- Good general and current knowledge of NHS developments and strategies relevant to medicines quality including primary and secondary care
- Specialist knowledge of clean room design, technology and operation for pharmaceutical processing
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
- Thorough understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
- Comprehensive understanding of pharmacy law and regulations n relation to manufacture, preparation and supply of medicines, including clinical trials
Desirable
- Good knowledge of ATMPs
- Awareness of national pharmaceutical contracting strategies including outsourced medicine compounding and homecare services
- Understanding of health and safety legislation as applicable to medicines manufacture and preparation
Skills
Essential
- Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or when dealing with uncertainty to inform professional judgement
- Excellent presentation and facilitation skills within small groups, large workshops and virtual audiences
- Self-motivated with excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities. Ability to work effectively on own and as part of a multidisciplinary team
- Excellent investigational and analytical skills with an ability to provide advice in highly complex situations
- Excellent interpersonal skills. Diplomatic, consultative and able to build consensus to successfully gain agreement and commitment with peers and customers Able to cope with conflict and handle difficult situations with a calm disposition
- Demonstrates tact, empathy and diplomacy when communicating confidential sensitive or contentious information
- Demonstrates leadership management negotiation, influencing and motivational skills to facilitate working across healthcare systems
- Ability to coach and mentor others
- Good IT skills ability to accurately produce documentation and presentations using Microsoft packages
Other
Essential
- Able to change into the appropriate clothing and spend time in pharmaceutical clean rooms and clinical areas
- Able to travel to anywhere in the East of England
Desirable
- Facility for remote/home working
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).
