Job summary
Closing date 24th March /
Interviews 1st April
We
are looking for a registered Pharmacist who is looking for the next step to
progress their career in pharmaceutical quality assurance with this
leadership role.
As
well as the standard NHS benefits, this is a great opportunity to work
alongside like-minded professionals in a dynamic, collaborative, and
supportive environment with a varied portfolio of work to support patient
care at LTHT. This post is an excellent opportunity to both showcase, and
develop, your leadership skills and expertise. This is a great time to join
our department as we are part of a national programme to transform aseptic
services in England, with West Yorkshire Association of Acute Trusts (WYAAT)
identified as one of five pathfinder sites.
The
QA/QC team is growing prior to our movement to our new build premises in
2026. The new facility will
manufacture medicines on behalf of the WYAAT collaborative, which sees
hospitals working together to provide the best possible care for patients in
West Yorkshire and Harrogate. The
post holder will join our existing QA/QC team, part of Pharmacy Preparative
Services within LTHT - one of the busiest in the UK. Their role will be
primarily to perform quality assurance activities to support our MS Licensed
Pharmacy Manufacturing Unit and our Section 10 Aseptic Service to produce
specialist medicines and infusions.
Main duties of the job
Duties
will include but are not limited to:
Support
the Service Manager to provide oversight & leadership to the QA/QC
Team.
Ensure
the effective management of the Pharmaceutical Quality System e.g. quality
risk management, root cause analysis, out of specification results and change
management.
Provide
subject matter expertise in relation to GMP, Pharmaceutical Quality Assurance
activities and Quality Risk Management.
Plan
and manage projects to support continuous improvement within LTHT Preparative
Services.
Ensure
that all activity performed within the scope of the MHRA MS Licence &
WDA(H) Authorisation comply with the relevant regulations and guidance.
Ensure
that staff are highly trained and assessed against current procedures and
competencies. This involves working closely with the department Team Leaders
and other Education and Training Teams.
Act
as a Releasing Officer in the dispensary support unit and aseptic production
unit.
Provide
QA leadership and support to the LTHT (Section 10) Preparative Services
departments.
Provide
support and training to other staff members within the LTHT team.
Line
management of substantive staff +/- trainees.
The
post is full-time, working 37.5 hours per week Monday-Friday. Flexible
working options can be discussed.
There will also be some Bank Holiday and weekend commitments (13 days
per year).
Interviews
will be held on 1 April 2025.
About us
Leeds
Teaching Hospitals is one of the largest and busiest NHS Trusts in the
country, offering a range of both general and specialist hospital services
with excellent clinical outcomes for patients. We have an international
reputation for excellence in specialist care, research and academic training.
We
are also part of the West Yorkshire Association of Acute Trusts (WYAAT), a
collaborative of the NHS hospital trusts from across West Yorkshire and
Harrogate working together to provide the best possible care for our
patients.
The
Pharmacy Department at LTHT is highly respected, forward thinking and
recognised within the organisation for collaborative working. We offer
excellent career progression whilst working in a friendly and supportive
team.
The
QA/QC team has been instrumental in supporting the LTHT Pharmacy
Manufacturing Unit in developing an industry leading service, producing ready
to administer injectable medicines.
Leeds
Teaching Hospitals is committed to our process of redeploying 'at risk'
members of our existing workforce to new roles. As such, all our job adverts
are subject to this policy and we reserve the right to close, delay or remove
adverts while this process is completed. If you do experience a delay in the
shortlisting stage of the recruitment cycle, please bear with us while this
process is completed, and contact the named contact if you have any
questions.
Job description
Job responsibilities
PRINCIPAL
DUTIES & AREAS OF RESPONSIBILITY
General
and Clinical
Supports the Trust's Prescribing
Standards and challenges practice where prescribers have not adhered to the
Medicines Code.
Manages difficult problems
including providing advice on production, COSHH issues and issues relating to
safe use of unlicensed medicines. In some situations information may be
ambiguous or limited and opinions may differ on preferred outcomes
Undertakes risk management,
including investigating clinical incidents, and ensuring compliance with
medicines legislation.
Undertakes risk management
including investigating errors and non-conformances in Preparative Services
and COSHH incidents in any Trust area.
The post holder will be expected to
identify, where necessary, areas that require service changes and develop a
strategy to carry out the change in accordance with the change control
procedure. The service changes identified may be internal to Preparative
Services or impact the service as a whole.
Manages the introduction of new
drugs, including quality assessment of unlicensed drugs.
Preparative
Services:
Professional Release of Licensed
Batch Manufacture - This activity involves being responsible for the quality
and safety of released batches of intravenous preparations manufactured in
the Aseptic Production Unit under the terms of the MHRA (Medicines &
Healthcare Regulatory Agency) Specials Licence.
It also involves being responsible
for the quality and safety of individual
released batches of oral and topical preparations manufactured in the Dispensary Support Unit
under the terms of the MHRA Specials Licence. Products prepared in this unit
are supplied to LTHT and other users within the local Health economy
including Local Care Direct and local health Trusts.
Supports the QA/QC manager in
ensuring that all licensed medicine preparation within the Trust is carried
out accordance with cGMP.
Professional Supervision of Aseptic
Dispensing. Working on a rota as part of a team of pharmacists, the job
holder will be responsible for supervising aseptic dispensing sessions and
releasing products.
May be expected to gain experience
in Radiopharmacy and provide professional support to this area as required.
Performs pharmaceutical quality
assessment of unlicensed medicines including approval of Quality Assessment
reports on individual medicines. To include quality risk assessment where
information on either the drug or the clinical usage is limited or conflicting.
Delivers training sessions on COSHH
and Risk Assessment to multidisciplinary groups.
Develops and maintains Quality
Systems and Information Resources
Assists the QC/QA Manager in Health
and Safety/Risk Management
Participates in research and
development activities within speciality including formulation and product
development.
Plans and performs GMP and GDP
audits in MHRA licensed facilities and all other Preparative Services areas.
Plans and performs Governance
Audits in Preparative Services dispensing areas.
Supervises, teaches, and assesses
junior pharmacy staff completing training modules within QA/QC and develop
suitable training programmes
Job description
Job responsibilities
PRINCIPAL
DUTIES & AREAS OF RESPONSIBILITY
General
and Clinical
Supports the Trust's Prescribing
Standards and challenges practice where prescribers have not adhered to the
Medicines Code.
Manages difficult problems
including providing advice on production, COSHH issues and issues relating to
safe use of unlicensed medicines. In some situations information may be
ambiguous or limited and opinions may differ on preferred outcomes
Undertakes risk management,
including investigating clinical incidents, and ensuring compliance with
medicines legislation.
Undertakes risk management
including investigating errors and non-conformances in Preparative Services
and COSHH incidents in any Trust area.
The post holder will be expected to
identify, where necessary, areas that require service changes and develop a
strategy to carry out the change in accordance with the change control
procedure. The service changes identified may be internal to Preparative
Services or impact the service as a whole.
Manages the introduction of new
drugs, including quality assessment of unlicensed drugs.
Preparative
Services:
Professional Release of Licensed
Batch Manufacture - This activity involves being responsible for the quality
and safety of released batches of intravenous preparations manufactured in
the Aseptic Production Unit under the terms of the MHRA (Medicines &
Healthcare Regulatory Agency) Specials Licence.
It also involves being responsible
for the quality and safety of individual
released batches of oral and topical preparations manufactured in the Dispensary Support Unit
under the terms of the MHRA Specials Licence. Products prepared in this unit
are supplied to LTHT and other users within the local Health economy
including Local Care Direct and local health Trusts.
Supports the QA/QC manager in
ensuring that all licensed medicine preparation within the Trust is carried
out accordance with cGMP.
Professional Supervision of Aseptic
Dispensing. Working on a rota as part of a team of pharmacists, the job
holder will be responsible for supervising aseptic dispensing sessions and
releasing products.
May be expected to gain experience
in Radiopharmacy and provide professional support to this area as required.
Performs pharmaceutical quality
assessment of unlicensed medicines including approval of Quality Assessment
reports on individual medicines. To include quality risk assessment where
information on either the drug or the clinical usage is limited or conflicting.
Delivers training sessions on COSHH
and Risk Assessment to multidisciplinary groups.
Develops and maintains Quality
Systems and Information Resources
Assists the QC/QA Manager in Health
and Safety/Risk Management
Participates in research and
development activities within speciality including formulation and product
development.
Plans and performs GMP and GDP
audits in MHRA licensed facilities and all other Preparative Services areas.
Plans and performs Governance
Audits in Preparative Services dispensing areas.
Supervises, teaches, and assesses
junior pharmacy staff completing training modules within QA/QC and develop
suitable training programmes
Person Specification
Experience
Essential
- Highly advanced knowledge and understanding of the principles of cGMP and cGDP
Desirable
- An understanding of team dynamics and effective leadership strategies to optimise performance
Skills & behaviours
Essential
- Be highly adaptive to changing circumstances and situations
- Highly developed influencing and negotiating skills
Qualifications
Essential
- Masters degree in Pharmacy
- Registrant of the GPhC
- Post qualification experience (min requirement to act as releasing officer in MHRA licenced unit)
Person Specification
Experience
Essential
- Highly advanced knowledge and understanding of the principles of cGMP and cGDP
Desirable
- An understanding of team dynamics and effective leadership strategies to optimise performance
Skills & behaviours
Essential
- Be highly adaptive to changing circumstances and situations
- Highly developed influencing and negotiating skills
Qualifications
Essential
- Masters degree in Pharmacy
- Registrant of the GPhC
- Post qualification experience (min requirement to act as releasing officer in MHRA licenced unit)
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).
