Job summary
Are
you a talented Scientist or Pharmacy Technician with experience in GMP, Quality
Assurance (QA) or Quality Control (QC)? Are you looking to improve patient care
by supporting the production of specialist medicines and infusions?
Do
you enjoy working in a dynamic, collaborative, and supportive environment with
a varied portfolio of work?
This
is an excellent opportunity to showcase your skills, whist benefiting from
access to great training and development opportunities.
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 at Leeds Teaching Hospitals (LTHT) is therefore expanding to support
the build of a new Pharmacy Aseptic Hub. 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 and quality control activities to support
our Pharmacy Manufacturing Unit to produce specialist medicines and infusions.
If you are passionate about making a difference this
will be a great opportunity to be part of the building the future of a highly
valued service.
Main duties of the job
Duties
will include but are not limited to:
Plan and manage projects to support
continuous improvement within LTHT Preparative Services.
Act as a Releasing Officer / QC
Checker in the dispensary support unit +/- aseptic production unit.
Oversight, supervision and
troubleshooting for QC laboratory activity (Chemistry +/- Microbiology) and
physical environmental monitoring and temperature monitoring activities.
Performing activities in relation to
the Pharmaceutical Quality System e.g. quality risk management, root cause
analysis, investigating out of specification results and change management.
Act as a Quality Controller for
Medical Gas Pipeline Systems
Provide QA related support to the
LTHT (Section 10) Preparative Services departments.
To manage the policies, procedures
and equipment used within the QA/QC service and ensure regulatory compliance
with GLP & GMP.
Provide support and training to other
staff members within the LTHT team.
Support validation activities within
MMPS.
About us
LTHT
is one of the largest and busiest acute hospital trusts in the UK. The Leeds
Way provides a strong foundation for the way we all work together, acting with
compassion, empathy, and kindness towards our patients and each other.
The
Pharmacy Department at LTHT is highly respected, forward thinking and
recognised within the organisation for collaborative working. Our vision is,
making it easy for people to get the most from their medicines and we are
continually innovating to improve our services for patients and staff.
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. The QA/QC team benefits from a supportive and innovative
environment.
The
department aims to support flexible working arrangements and we have car
parking on site.
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
This
post will work with the QA/QC Manager and QA Pharmacist in ensuring that all
MHRA licensed medicine preparation and distribution within the LTHT MS Licensed
facility is carried out in accordance with relevant regulations and cGxP.
The
post-holder also acts as a Releasing Officer for the Aseptic Preparation Unit
+/- Dispensary Support Unit under the terms of the MHRA Specials Licence.
The
post-holder will work in partnership with the QA/QC Manager in ensuring that
all unlicensed LTHT Aseptic and Radiopharmacy facilities are operating in
accordance with current guidance and cGMP.
In
addition to supporting compounding activities at LTHT, this post will
facilitate the delivery of high quality patient care by ensuring safety and
quality of all products supplied to LTHT and external NHS customers. This
includes supporting the specification, development and procurement of new
products and provision of highly specialist advice e.g. the quality assessment
of unlicensed medicines.
Contribute
to training pharmacists, technicians, and pharmacy support workers on aspects
of Good Manufacturing Practice (cGMP) and other QA/QC procedures within
Preparative Services, MMPS and Trustwide where appropriate
Manage
other staff providing specialised preparative and/or QC/QA services.
Under
the leadership of the QC/QA Manager and the service managers, ensure all
records within the electronic Pharmaceutical Quality System are complete and
accurate. Reviews and develops the system as required.
Produces
periodic Assurance reports in relation to the Pharmaceutical Quality System as
required.
Provide a minimum of at least three 4 hour sessions of
service cover in the Pharmacy Manufacturing Unit, aseptic dispensary and/or
radiopharmacy each week.
Job description
Job responsibilities
This
post will work with the QA/QC Manager and QA Pharmacist in ensuring that all
MHRA licensed medicine preparation and distribution within the LTHT MS Licensed
facility is carried out in accordance with relevant regulations and cGxP.
The
post-holder also acts as a Releasing Officer for the Aseptic Preparation Unit
+/- Dispensary Support Unit under the terms of the MHRA Specials Licence.
The
post-holder will work in partnership with the QA/QC Manager in ensuring that
all unlicensed LTHT Aseptic and Radiopharmacy facilities are operating in
accordance with current guidance and cGMP.
In
addition to supporting compounding activities at LTHT, this post will
facilitate the delivery of high quality patient care by ensuring safety and
quality of all products supplied to LTHT and external NHS customers. This
includes supporting the specification, development and procurement of new
products and provision of highly specialist advice e.g. the quality assessment
of unlicensed medicines.
Contribute
to training pharmacists, technicians, and pharmacy support workers on aspects
of Good Manufacturing Practice (cGMP) and other QA/QC procedures within
Preparative Services, MMPS and Trustwide where appropriate
Manage
other staff providing specialised preparative and/or QC/QA services.
Under
the leadership of the QC/QA Manager and the service managers, ensure all
records within the electronic Pharmaceutical Quality System are complete and
accurate. Reviews and develops the system as required.
Produces
periodic Assurance reports in relation to the Pharmaceutical Quality System as
required.
Provide a minimum of at least three 4 hour sessions of
service cover in the Pharmacy Manufacturing Unit, aseptic dispensary and/or
radiopharmacy each week.
Person Specification
Experience
Essential
- Good dispensing, distribution & manufacturing practice
- Accuracy checking training
Desirable
- Knowledge of clean room design and functioning
- Risk assessments
Other Criteria
Essential
- Able to cope with a large and varied workload
- Able to work accurately and under pressure
- Good IT skills (Excel, Word and Powerpoint)
Qualifications
Essential
- Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or similar) OR BTEC in pharmaceutical science or NVQ level 3 in pharmacy services
- Eligible for registration with the Health and Care Professions Council (HCPC), General Pharmaceutical Council (GPhC), Royal Society of Chemistry (RSC), Institute of Biology or equivalent
Desirable
- Further education in Pharmacy Technical Services e.g. PTQA or STP
Skills and Behaviours
Essential
- Enthusiastic & reliable
- Professionalism
Person Specification
Experience
Essential
- Good dispensing, distribution & manufacturing practice
- Accuracy checking training
Desirable
- Knowledge of clean room design and functioning
- Risk assessments
Other Criteria
Essential
- Able to cope with a large and varied workload
- Able to work accurately and under pressure
- Good IT skills (Excel, Word and Powerpoint)
Qualifications
Essential
- Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or similar) OR BTEC in pharmaceutical science or NVQ level 3 in pharmacy services
- Eligible for registration with the Health and Care Professions Council (HCPC), General Pharmaceutical Council (GPhC), Royal Society of Chemistry (RSC), Institute of Biology or equivalent
Desirable
- Further education in Pharmacy Technical Services e.g. PTQA or STP
Skills and Behaviours
Essential
- Enthusiastic & reliable
- Professionalism
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).
