Job summary
We
are looking for a Scientist or Pharmacy Technician with experience of working
in a pharmaceutical manufacturing environment, particularly in a quality
related role.
As
well as the standard NHS benefits, this is a fantastic 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 holder will be able to both showcase and develop
their quality management expertise.
This
is an exciting time to join us 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 Englands pathfinder sites. Our
team is expanding to support the build of a new Aseptic Hub to manufacture
medicines for the WYAAT collaborative, with hospitals in the region working
together for the best possible patient care.
As
well as performing QC checks on pharmaceutical batches for the aseptic
preparation unit and dispensary support unit, you will also be involved in
the management of the quality system and implementing exciting new projects
throughout the manufacturing facility.
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
This
1-year fixed term role will focus on:
i) QC checking of pharmaceutical
batches manufactured under our Specials licence.
ii) Final accuracy checking in our
Section 10 Pharmacy Aseptic Units.
iii) Supporting the management and
maintenance of the Quality Management System.
iv) Supporting change management
throughout the department.
v) Co-ordination, organisation and
implementation of departmental schedules and action plans.
vi) Training of other team members,
students, and the wider Pharmacy Department.
The
post is full-time, working 37.5 hours per week Monday-Friday. There will also
be some Bank Holiday and weekend commitments (13 days per year). The
department aims to support flexible working arrangements, and we have car
parking on site.
We are happy to consider internal secondments for this post
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. 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.
We
are proud to say that we have created a positive working environment with a
hardworking and dedicated workforce who feel valued and share a team goal to
put the patients first.
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
Ensures aseptic preparation is
carried out efficiently and responsively and in compliance with current
legislation and standards and the principles of Good Manufacturing Practice.
Ensures equipment and facilities
are subject to an appropriate programme of validation
Ensures (in liaison with service
managers) that the following are undertaken.
- Physical and Environmental
Monitoring
- Operator and Process Validation
- Audit (and subsequent action
planning)
Leads a small team of technical and
support staff, as required, in the Quality Assurance Service ensuring they
have appropriate induction, regular appraisals, personal development plans
and challenging but realistic objectives. Conducts sickness and disciplinary
reviews as required.
Ensure Trust Absence Management
policy is adhered to and that staff absence is reported and return to work
interviews conducted in a timely manner.
Responsible for limited recruitment
and selection of technical and support staff within the service
Ensures regular team briefings and
meetings are held and that there is good communication for all staff using a
variety of means, written and verbal.
Provides operational support to the
service, including sessional supervision and accuracy checking +/- final
product approval. This will usually be on a planned basis.
Maintains high professional
standards at all times and ensure compliance with statutory regulations
concerning pharmaceuticals and the provision of Health and Safety at work are
complied with
Promotes the cost-effective use of
equipment and supplies and to ensure that appropriate ordering and costing
procedures are in place.
Participates in regular internal
audits of the service and take action to remedy and deficiencies to
continually improve the quality of the service.
Works with key stakeholders in
ensuring the delivery of training and competency assessments for staff
working within the preparative service, including supporting the assessment
of NVQ candidates.
Contributes to pharmacy service
developments and ensure that change is managed smoothly in relation to area
of responsibility.
Leads the implementation of new
changes, based on best evidence or expert scientific opinion.
Identifies and implements risk
reduction strategies in preparative service areas, in support of the
Preparative Services Leadership Team.
Develops efficient communication
channels with the rest of pharmacy and key customers to ensure a good
understanding of the service and the roles and responsibilities of staff
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
Quality assessment of unlicensed
medicines
Critical review of stability
studies and related product literature
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 management team
in ensuring that all licensed medicine preparation within the Trust is
carried out accordance with cGMP.
Final Accuracy Checking +/- final
product approval in the unlicensed aseptic dispensaries
Assists in Health and Safety
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.
Provides scientific support and
advice to the MMPS Leadership team on a range of issues, including those
outside the Preparative Service.
Supervises, teaches, and assesses
junior pharmacy staff completing training modules within preparative services
Job description
Job responsibilities
Ensures aseptic preparation is
carried out efficiently and responsively and in compliance with current
legislation and standards and the principles of Good Manufacturing Practice.
Ensures equipment and facilities
are subject to an appropriate programme of validation
Ensures (in liaison with service
managers) that the following are undertaken.
- Physical and Environmental
Monitoring
- Operator and Process Validation
- Audit (and subsequent action
planning)
Leads a small team of technical and
support staff, as required, in the Quality Assurance Service ensuring they
have appropriate induction, regular appraisals, personal development plans
and challenging but realistic objectives. Conducts sickness and disciplinary
reviews as required.
Ensure Trust Absence Management
policy is adhered to and that staff absence is reported and return to work
interviews conducted in a timely manner.
Responsible for limited recruitment
and selection of technical and support staff within the service
Ensures regular team briefings and
meetings are held and that there is good communication for all staff using a
variety of means, written and verbal.
Provides operational support to the
service, including sessional supervision and accuracy checking +/- final
product approval. This will usually be on a planned basis.
Maintains high professional
standards at all times and ensure compliance with statutory regulations
concerning pharmaceuticals and the provision of Health and Safety at work are
complied with
Promotes the cost-effective use of
equipment and supplies and to ensure that appropriate ordering and costing
procedures are in place.
Participates in regular internal
audits of the service and take action to remedy and deficiencies to
continually improve the quality of the service.
Works with key stakeholders in
ensuring the delivery of training and competency assessments for staff
working within the preparative service, including supporting the assessment
of NVQ candidates.
Contributes to pharmacy service
developments and ensure that change is managed smoothly in relation to area
of responsibility.
Leads the implementation of new
changes, based on best evidence or expert scientific opinion.
Identifies and implements risk
reduction strategies in preparative service areas, in support of the
Preparative Services Leadership Team.
Develops efficient communication
channels with the rest of pharmacy and key customers to ensure a good
understanding of the service and the roles and responsibilities of staff
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
Quality assessment of unlicensed
medicines
Critical review of stability
studies and related product literature
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 management team
in ensuring that all licensed medicine preparation within the Trust is
carried out accordance with cGMP.
Final Accuracy Checking +/- final
product approval in the unlicensed aseptic dispensaries
Assists in Health and Safety
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.
Provides scientific support and
advice to the MMPS Leadership team on a range of issues, including those
outside the Preparative Service.
Supervises, teaches, and assesses
junior pharmacy staff completing training modules within preparative services
Person Specification
Skills and Behaviours
Essential
- Able to cope with a large and varied workload
- Able to work accurately and under pressure
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 body
Desirable
- Further education in Pharmacy Technical Services e.g. PTQA or STP
Experience
Essential
- Experience of aseptic preparation
- Accuracy checking training
- Good dispensing, distribution, manufacturing practice
- Incident and error reporting
Desirable
- Managing change
- Risk assessments
Person Specification
Skills and Behaviours
Essential
- Able to cope with a large and varied workload
- Able to work accurately and under pressure
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 body
Desirable
- Further education in Pharmacy Technical Services e.g. PTQA or STP
Experience
Essential
- Experience of aseptic preparation
- Accuracy checking training
- Good dispensing, distribution, manufacturing practice
- Incident and error reporting
Desirable
- Managing change
- Risk assessments
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).
