Job summary
We have an exciting opportunity for a highly motivated, experienced pharmacist wishing to take on a leadership role in Quality Control and Quality Assurance
As a key member of the Pharmacy Technical Services Management Team, you will be named as responsible for Quality on our MS Licence and will support all the MS and WDA(H) licensable activity in the Health Board.
This includes Pharmacy Aseptic Preparation and Manufacturing (Singleton), Radiopharmacy Aseptic manufacturing (Singleton), pre-packing and over labelling (Neath) and all WDA(H) licence activities.
This is an exciting time to be involved with Pharmacy Technical Services in Wales. The Wales-wide project - Transforming Access to Medicines (TRAMs) - is currently being developed. This aims to develop a sustained programme of investment and reconfiguration of Pharmacy Technical Services, to build capacity, reduce risk, and safeguard delivery of these critically important services to patients for the long term.
We are looking for the right person to fit into the team, and work with all our stakeholders. If you feel that you have the required experience, skills and knowledge and are ready to be the Head of QA&C in a busy Health Board please get in touch.
Main duties of the job
The post holder will be based at Singleton Hospital and will work closely with Production leads to manage quality and risk assurance for the MHRA licensed units. The post holder will also be responsible for managing unlicensed medicines, responsible for a product evaluation and risk assessment system for unlicensed medicines procured and issued with the UHB. The successful applicant will also provide QA support for the Health Board Wholesale Dealer Authority licences and medical gases.
The successful candidate needs to be passionate about Quality Control and Assurance and must be able to inspire and give direction to an enthusiastic and experienced team of pharmacists, STPs, technicians and support staff working within the QC and the production units.
The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.
About us
We believe staff are our best asset and wewant you to be happy and confident about starting your career here in Swansea Bay University Health Board.
As one of the biggest healthcare groups in the UK we can offer a wealth of professional training and development opportunities in an innovative, forward-thinking organisation.
You might be a nurse ordoctor, maybe you specialise in a health science/therapy or can offer skills in one of our support services - wehave a job for you.
There are also apprenticeships, work placementsand volunteering roles available.
We are an inclusive employer and welcome applications from everyone whatever their sex; religion or belief; race; age; sexual orientation; gender identity or, whether they are pregnant or have recently been on maternity leave, married or are in a civil partnership; or, whether they are disabled.
Our values - Caring For Each Other, Working Together and Always Improving, show thatour commitment to equality is at the heart of everything we do.
If you want excellent career and training opportunities while living on the doorstep of some of Europe's most spectacular scenery,with all the benefits of a thriving and cosmopolitan city - look no further.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
Job description
Job responsibilities
Accountable and responsible for the delivery of the Pharmacy Quality Assurance & Quality Control Service.
Lead a robust Pharmacy Quality System (PQS) across all areas of pharmacy services ensuring compliance with statutory regulations and safe systems of work.
Ensure the quality of medicines used in the Health Board through application of Quality Management Systems in procurement, storage and supply processes.
Manage the staff and resources of the Pharmacy Quality Assurance & Quality Control department.
Develop and implement strategic plans for the Pharmacy Quality Assurance & Quality Control Service, ensuring the service is progressive and responsive to the needs of the Health Board.
Maintain appropriate MHRA medicines specials manufacturing and distribution licenses to support the Health Board strategic plans.
The named as the person responsible for Quality Control on the Health Boards MHRA specials manufacturing licence (approved by the MHRA). Accountable and responsible for the release of medicinal products manufactured under the Health Boards MHRA specials manufacturing license.
Be the named Responsible Person on the Health Boards MHRA wholesale dealers license (approved by the MHRA). Accountable and responsible for the supply and distribution of medicines under the MHRA wholesale dealers license WDA(H).
Undertake internal audit of pharmaceutical manufacturing and distribution (i.e. wholesale dealing) sites within the Health Board.
Provide expert advice on all aspects of the quality of unlicensed medicines purchased, manufactured and supplied within the Health Board.
Advise on regulatory matters relating to the purchase, storage, manufacture and supply of medicines within the Health Board (including the wholesale supply of medicines under MHRA WDA(H) licence).
Provide pharmaceutical expertise to the Health Boards Medical Gas Committee, promoting good clinical practice in the use and handling of medical gases. Act as the Lead Quality Controller for the medical gas pipeline systems as required by the HTM 02-01.
Job description
Job responsibilities
Accountable and responsible for the delivery of the Pharmacy Quality Assurance & Quality Control Service.
Lead a robust Pharmacy Quality System (PQS) across all areas of pharmacy services ensuring compliance with statutory regulations and safe systems of work.
Ensure the quality of medicines used in the Health Board through application of Quality Management Systems in procurement, storage and supply processes.
Manage the staff and resources of the Pharmacy Quality Assurance & Quality Control department.
Develop and implement strategic plans for the Pharmacy Quality Assurance & Quality Control Service, ensuring the service is progressive and responsive to the needs of the Health Board.
Maintain appropriate MHRA medicines specials manufacturing and distribution licenses to support the Health Board strategic plans.
The named as the person responsible for Quality Control on the Health Boards MHRA specials manufacturing licence (approved by the MHRA). Accountable and responsible for the release of medicinal products manufactured under the Health Boards MHRA specials manufacturing license.
Be the named Responsible Person on the Health Boards MHRA wholesale dealers license (approved by the MHRA). Accountable and responsible for the supply and distribution of medicines under the MHRA wholesale dealers license WDA(H).
Undertake internal audit of pharmaceutical manufacturing and distribution (i.e. wholesale dealing) sites within the Health Board.
Provide expert advice on all aspects of the quality of unlicensed medicines purchased, manufactured and supplied within the Health Board.
Advise on regulatory matters relating to the purchase, storage, manufacture and supply of medicines within the Health Board (including the wholesale supply of medicines under MHRA WDA(H) licence).
Provide pharmaceutical expertise to the Health Boards Medical Gas Committee, promoting good clinical practice in the use and handling of medical gases. Act as the Lead Quality Controller for the medical gas pipeline systems as required by the HTM 02-01.
Person Specification
Qualifications
Essential
- Master's Pharmacy
- Member General Pharmaceutical Council MRPharmS
- Postgraduate pharmacy qualification (e.g. Diploma in PTQA)
- Awareness of Welsh Government / Department of Health Strategies for the NHS
- Awareness of potential role for hospital pharmacy services in the changing NHS
- Knowledge of health services developments which will impact on hospital pharmacy services
- Good Manufacturing Practice
- Good Distribution Practice
- Good Laboratory Practice
Desirable
- Postgraduate management qualification
- Member of the RPS Faculty
- Management training
- Training in education/ professional development
Experience
Essential
- Extensive relevant postgraduate experience in pharmaceutical manufacturing, including experience in large MHRA licensed facility
- Experience of managing and developing a pharmaceutical Quality Assurance & Quality Control Service
- Experience of strategy development and management of change
- Successful service development
- Demonstrate ability to identify problems, analyse root cause and propose solutions for complex problems
- Ability to use complex laboratory and testing equipment, and to train others in its use
Desirable
- A thorough knowledge of hospital pharmacy technical services (e.g. clean room design, isolator technology, production methodology, QA & QC, etc.)
Aptitude and abilities
Essential
- Can demonstrate SBU values
- Leadership skills and ability to influence and negotiate within the service, HB and external
- Good oral and written communication skills
- Multidisciplinary team working
- Prioritisation and time management
- Commitment to own CPD and ability to acquire new skills and to develop others
- Confident and emotionally resilient
Desirable
- Welsh Speaker (Level 1)
- Credible profile within hospital pharmacy technical services in the UK
Person Specification
Qualifications
Essential
- Master's Pharmacy
- Member General Pharmaceutical Council MRPharmS
- Postgraduate pharmacy qualification (e.g. Diploma in PTQA)
- Awareness of Welsh Government / Department of Health Strategies for the NHS
- Awareness of potential role for hospital pharmacy services in the changing NHS
- Knowledge of health services developments which will impact on hospital pharmacy services
- Good Manufacturing Practice
- Good Distribution Practice
- Good Laboratory Practice
Desirable
- Postgraduate management qualification
- Member of the RPS Faculty
- Management training
- Training in education/ professional development
Experience
Essential
- Extensive relevant postgraduate experience in pharmaceutical manufacturing, including experience in large MHRA licensed facility
- Experience of managing and developing a pharmaceutical Quality Assurance & Quality Control Service
- Experience of strategy development and management of change
- Successful service development
- Demonstrate ability to identify problems, analyse root cause and propose solutions for complex problems
- Ability to use complex laboratory and testing equipment, and to train others in its use
Desirable
- A thorough knowledge of hospital pharmacy technical services (e.g. clean room design, isolator technology, production methodology, QA & QC, etc.)
Aptitude and abilities
Essential
- Can demonstrate SBU values
- Leadership skills and ability to influence and negotiate within the service, HB and external
- Good oral and written communication skills
- Multidisciplinary team working
- Prioritisation and time management
- Commitment to own CPD and ability to acquire new skills and to develop others
- Confident and emotionally resilient
Desirable
- Welsh Speaker (Level 1)
- Credible profile within hospital pharmacy technical services in the UK
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).
