Job summary
Are
you a talented Scientist, Pharmacist or Pharmacy Technician with experience in
GMP and Quality Assurance looking to improve patient care?
Do
you enjoy working in a dynamic, collaborative, and supportive environment with
a varied portfolio of work?
This
is an excellent opportunity to showcase, and continue to 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 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 activities to support our MS Licensed
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:
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 related 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.
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
Works in partnership with the QA/QC
Manager in ensuring that all MHRA licensed medicine preparation and
distribution within facility at Moor House is carried out in accordance with
relevant regulations and cGxP.
Acts as a Releasing Officer for the
Aseptic Preparation Unit and Dispensary Support Unit under the terms of the
MHRA Specials Licence.
Works 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.
Works in partnership with the
delivery of high-quality patient care by ensuring safety and quality of all
products supplied to LTHT and external NHS customers. This includes the
development of new products and provision of highly specialist advice.
Responsible for training pharmacists,
and other health care professionals, on aspects of Good Manufacturing Practice
(cGMP) and other QA/QC procedures within Preparative Services, MMPS and
Trustwide where appropriate.
Ensures medicines are used
appropriately, safely, and cost-effectively in accordance with Trust policy,
standard operating procedures and medicine legislation. The post holder is
expected to determine how the outcomes are best achieved in specific
circumstances.
Manages other staff providing
specialised QC/QA services.
Ensures
all records within the electronic Quality Management System for the Licenced
units are complete and accurate and produces monthly Assurance Reports. Reviews
and develops the system as required.
Job description
Job responsibilities
Works in partnership with the QA/QC
Manager in ensuring that all MHRA licensed medicine preparation and
distribution within facility at Moor House is carried out in accordance with
relevant regulations and cGxP.
Acts as a Releasing Officer for the
Aseptic Preparation Unit and Dispensary Support Unit under the terms of the
MHRA Specials Licence.
Works 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.
Works in partnership with the
delivery of high-quality patient care by ensuring safety and quality of all
products supplied to LTHT and external NHS customers. This includes the
development of new products and provision of highly specialist advice.
Responsible for training pharmacists,
and other health care professionals, on aspects of Good Manufacturing Practice
(cGMP) and other QA/QC procedures within Preparative Services, MMPS and
Trustwide where appropriate.
Ensures medicines are used
appropriately, safely, and cost-effectively in accordance with Trust policy,
standard operating procedures and medicine legislation. The post holder is
expected to determine how the outcomes are best achieved in specific
circumstances.
Manages other staff providing
specialised QC/QA services.
Ensures
all records within the electronic Quality Management System for the Licenced
units are complete and accurate and produces monthly Assurance Reports. Reviews
and develops the system as required.
Person Specification
Qualifications
Essential
- MPharm degree or honours degree in relevant discipline (see full job description) or qualification in pharmaceutical science (BTEC) or equivalent .
- Postgraduate Diploma in Clinical Pharmacy and/or Pharmaceutical Technology
- 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
Skills and Behaviours
Essential
- Able to work under own initiative
- Lateral thinker and good problem solver
- Be able to plan effectively both own workload and that of specialist team
Experience
Essential
- Relevant post qualification experience (minimum requirement to act as releasing officer in MHRA licenced unit)
- Developed specialist knowledge and significant experience of working within technical or preparative services.
- Highly advanced knowledge and understanding principles of cGMP and cGDP
Person Specification
Qualifications
Essential
- MPharm degree or honours degree in relevant discipline (see full job description) or qualification in pharmaceutical science (BTEC) or equivalent .
- Postgraduate Diploma in Clinical Pharmacy and/or Pharmaceutical Technology
- 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
Skills and Behaviours
Essential
- Able to work under own initiative
- Lateral thinker and good problem solver
- Be able to plan effectively both own workload and that of specialist team
Experience
Essential
- Relevant post qualification experience (minimum requirement to act as releasing officer in MHRA licenced unit)
- Developed specialist knowledge and significant experience of working within technical or preparative services.
- Highly advanced knowledge and understanding principles of cGMP and cGDP
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).
