Job summary
The Specialist Pharmacy Service's (SPS) national Quality Assurance Service supports the principles of medicines optimisation by developing and championing 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 Deputy Regional Quality Assurance Pharmacist - North East and Yorkshire (NEY) will work as part of a regional and national team in delivering successful patient outcomes by ensuring medicines that are bought, prepared and supplied in the NHS are evidenced based, safe, and are of high quality. This will involve working closely with the pharmaceutical Industry and NHS manufacturing and preparation units.
By working as part of an integrated SPS team, the post-holder will be able to facilitate making medicines optimisation routine practice across the NHS and will promote equal and equitable service provision.
The post holder will deputise for the Regional Quality Assurance Pharmacists in their absence.
- Interview Date Tuesday, 13 February 2024
- 37 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
Main duties of the job
Providing support for NHS Organisations and Networks through the following:-
- To support the delivery of the national medicines optimisation agenda by providing specialist quality assurance advice at a national, regional and local level.
- Safeguarding patients through the quality assurance of medicines procured, prepared or manufactured by the NHS in the North East and Yorkshire Region.
- To contribute to the patient safety agenda through the provision of quality assurance expertise and support to the procurement, preparation and manufacture of medicines and medicines provider services to the NHS.
- Development and implementation of best practice standards for manufacturing medicines in the NHS through audit, training, mentoring and advice.
- To support 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.
- To promote innovation and transformation in the NHS by supporting the development, implementation and safe use of new medicines (e.g. ATMP, clinical trials, biological medicines) and technologies through working with regulators, academia and industry.
- Contribute to the development, implementation and delivery of the NHSE, SPS and NHS Pharmaceutical QA Committee work-plans.
About us
Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare.
Please see attached information on what Staff Benefits we have to offer at our Trust.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Job description
Job responsibilities
The post will be hosted by Newcastle upon Tyne Hospitals NHS Foundation Trust with remote working facilitating candidates to reside anywhere in the NEY Region and beyond. The role will involve a considerable amount of travelling, principally within the North East and Yorkshire Region but also to other areas of England. The peripatetic role will include auditing, development of collaborative initiatives, training/CPD support and attendance at relevant meetings and networks.
Duties include:
- To provide a complete and comprehensive response to enquiries and requests for information and advice.
- To facilitate/carry out research and development activities relevant to medicines manufacturing.
- To support management of medicines, management related quality, risk management and medicines optimisation issues by investigation, presentations and participation in local and national meetings and forums.
- To advise, assist and support senior pharmacy personnel in planning, designing and validating upgrading or building new clean rooms and other manufacturing and compounding facilities. This may require liaison with private finance initiative (PFI) architects, managers and contractors and assisting the trust involved with the project.
- To provide advice and support to QC laboratories and local services (e.g. those relating to aseptic preparation units).
In order to provide this advice the post holder will:
- Keep up to date with current standards of pharmacy practice, service developments and NHS initiatives in order to provide specialist advice to NHS pharmacy staff across the North East & Yorkshire.
- Keep up to date with current standards of good manufacturing practice, good distribution practice and good clinical practice and notify relevant NHS pharmacy staff across the Region of any changes to legislation or regulations governing the manufacturing, distribution and/or extemporaneous dispensing of medicines and investigational medicinal products.
- Predict where possible development needs that will arise from future NHS developments by horizon scanning, and devise strategies to meet these needs in conjunction with other colleagues.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate.The method of payment is a salary deduction from your first months pay.
Job description
Job responsibilities
The post will be hosted by Newcastle upon Tyne Hospitals NHS Foundation Trust with remote working facilitating candidates to reside anywhere in the NEY Region and beyond. The role will involve a considerable amount of travelling, principally within the North East and Yorkshire Region but also to other areas of England. The peripatetic role will include auditing, development of collaborative initiatives, training/CPD support and attendance at relevant meetings and networks.
Duties include:
- To provide a complete and comprehensive response to enquiries and requests for information and advice.
- To facilitate/carry out research and development activities relevant to medicines manufacturing.
- To support management of medicines, management related quality, risk management and medicines optimisation issues by investigation, presentations and participation in local and national meetings and forums.
- To advise, assist and support senior pharmacy personnel in planning, designing and validating upgrading or building new clean rooms and other manufacturing and compounding facilities. This may require liaison with private finance initiative (PFI) architects, managers and contractors and assisting the trust involved with the project.
- To provide advice and support to QC laboratories and local services (e.g. those relating to aseptic preparation units).
In order to provide this advice the post holder will:
- Keep up to date with current standards of pharmacy practice, service developments and NHS initiatives in order to provide specialist advice to NHS pharmacy staff across the North East & Yorkshire.
- Keep up to date with current standards of good manufacturing practice, good distribution practice and good clinical practice and notify relevant NHS pharmacy staff across the Region of any changes to legislation or regulations governing the manufacturing, distribution and/or extemporaneous dispensing of medicines and investigational medicinal products.
- Predict where possible development needs that will arise from future NHS developments by horizon scanning, and devise strategies to meet these needs in conjunction with other colleagues.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate.The method of payment is a salary deduction from your first months pay.
Person Specification
TRAINING, QUALIFICATIONS AND PROFESSIONAL REGISTRATIONS
Essential
- Degree in Pharmacy
- Registered with General Pharmaceutical Council (GPhC)
- Post graduate Masters qualification in quality assurance practice or equivalent specialist experience
- Postgraduate Masters in management or equivalent experience
Desirable
- Registered as Qualified Person
- MGPS(QC) as per HTM 2022
- Member of the Royal Pharmaceutical Society
EXPERIENCE & KNOWLEDGE
Essential
- Significant 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 multi-disciplinary 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 formulation, preparation and the assignment of appropriate shelf lives for prepared medicines
- Significant experience of working with regulatory authorities
- Significant experience of working in both regional and national networks
- Led on projects and or demonstrated an ability to direct their own work
- Current understanding of the NHS and the role of pharmacy within it
- 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 anmd 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
- Specialist knowledge of the standards and guidance relating to homecare medicines services
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
- Specialist knowledge of clean room design, technology and operation for pharmaceutical processing
- Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
- Understanding of health and safety legislation as applicable to medicines manufacture and preparation
Desirable
- Experience in all areas of hospital pharmacy services including dispensary, clinical services and storage and distribution
- Experience of quality control testing of medical gases from both cylinders and pipeline systems
- Experience of procurement of medicines and product assessment
- Understanding of medical gases, their distribution and use in hospitals
SKILLS & ABILITY
Essential
- Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or there are barriers to understanding
- Excellent presentation and facilitation skills within both small groups and large workshops
- Excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities
- 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 leadership management negotiation and motivational skills to facilitate working within and leading a team of staff
- Demonstrates tact, empathy and diplomacy when communicating confidential sensitive or contentious information
- Ability to coach and mentor others
- Ability to work effectively on own and as part of a multi-disciplinary team
- Able to concentrate for prolonged periods while dealing with interruptions
- Able to show empathy to colleagues under pressure
- Able to communicate clearly good and poor audit finding and actions necessary to more senior trust staff
- Able to challenge data or views expressed by colleagues
- Good internet skills to include searches and website management
- Good IT skills ability to accurately produce documentation and presentations using Microsoft packages
OTHER SPECIFIC REQUIREMENT
Essential
- Full UK driving licence / ability to travel between sites
Person Specification
TRAINING, QUALIFICATIONS AND PROFESSIONAL REGISTRATIONS
Essential
- Degree in Pharmacy
- Registered with General Pharmaceutical Council (GPhC)
- Post graduate Masters qualification in quality assurance practice or equivalent specialist experience
- Postgraduate Masters in management or equivalent experience
Desirable
- Registered as Qualified Person
- MGPS(QC) as per HTM 2022
- Member of the Royal Pharmaceutical Society
EXPERIENCE & KNOWLEDGE
Essential
- Significant 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 multi-disciplinary 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 formulation, preparation and the assignment of appropriate shelf lives for prepared medicines
- Significant experience of working with regulatory authorities
- Significant experience of working in both regional and national networks
- Led on projects and or demonstrated an ability to direct their own work
- Current understanding of the NHS and the role of pharmacy within it
- 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 anmd 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
- Specialist knowledge of the standards and guidance relating to homecare medicines services
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
- Specialist knowledge of clean room design, technology and operation for pharmaceutical processing
- Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
- Understanding of health and safety legislation as applicable to medicines manufacture and preparation
Desirable
- Experience in all areas of hospital pharmacy services including dispensary, clinical services and storage and distribution
- Experience of quality control testing of medical gases from both cylinders and pipeline systems
- Experience of procurement of medicines and product assessment
- Understanding of medical gases, their distribution and use in hospitals
SKILLS & ABILITY
Essential
- Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or there are barriers to understanding
- Excellent presentation and facilitation skills within both small groups and large workshops
- Excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities
- 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 leadership management negotiation and motivational skills to facilitate working within and leading a team of staff
- Demonstrates tact, empathy and diplomacy when communicating confidential sensitive or contentious information
- Ability to coach and mentor others
- Ability to work effectively on own and as part of a multi-disciplinary team
- Able to concentrate for prolonged periods while dealing with interruptions
- Able to show empathy to colleagues under pressure
- Able to communicate clearly good and poor audit finding and actions necessary to more senior trust staff
- Able to challenge data or views expressed by colleagues
- Good internet skills to include searches and website management
- Good IT skills ability to accurately produce documentation and presentations using Microsoft packages
OTHER SPECIFIC REQUIREMENT
Essential
- Full UK driving licence / ability to travel between sites
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).
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