Job summary
Expected Shortlisting
Date
01/10/2024
Planned Interview
Date
10/10/2024
This
is a great time to join the team as we are a national pathfinder (there are
only 5 others in England!) to build a new pharmacy aseptic medicines hub
which will support the West Yorkshire Association of Acute Trusts (WYAAT).
If
you are an enthusiastic and a self-motivated pharmacy technician or
production specialist with a passion for Technical Services and can demonstrate
high professional standards, this is the role for you. You'll need a keen
interest in clean rooms, Hydrogen Peroxide gassing technology and have
Pharmaceutical Quality System management experience and knowledge. You must
be able to react to early response events which occur with key equipment
and facilities. You'll be responsible for the re-validation of
equipment and operators and participate in the delivery of key technical
training to new staff and lead on service improvement.
We
are based in south Leeds and operate under an MHRA specials licence providing
high quality pharmaceutical IV medicines to patients.
The
post is a full-time post of 37.5 hours per week, to be worked over a 4 /5 day
working week between the hours of 7am-7pm. This post has a weekend and bank
holiday commitment on a rota basis.
Interviews
will be held on 10th October 2024
Main duties of the job
To
act as the lead for the Quality Assurance and MHRA legislation in the
Pharmacy Manufacturing Unit within Pharmacy Preparative Services.
Manage
service productivity, quality and safety according to Key Performance
Indicators, considering safe staffing and equipment capacity limits.
Support
the Production Manager to lead all production elements of the Pharmaceutical
Quality System (PQS) underpinned by the Electronic Management System (EQMS)
Be
responsible for ensuring that the legal and statutory requirements are met
regarding facilities, equipment, policy, procedures, and training.
Participate
in regular Internal Audits including Health and Safety Audits and follow up
actions.
You
will need advanced knowledge and understanding in the principles of GMP &
GDP.
To
work with the Pharmacy Preparative Services Management Team (PPSMT) to ensure
the smooth implementation of new, education and training focused, Information
Technology systems and procedures within pharmacy preparative services.
Line
management of staff including Pharmacy Technicians and Production
Specialists.
As
part of the PPSMT, work closely with the Production Manager, the Aseptic
Service Manager and the Radio pharmacy Manager in the development and
planning of the service, with a focus on workforce development and training.
To
perform a leadership role at weekends and bank holidays.
About us
Leeds
Teaching Hospitals is one of the biggest 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.
The
Pharmacy Department at LTHT is highly respected, forward thinking and
recognised within the organisation for collaborative working.
The
department is expanding to build a new Pharmacy Aseptic Medicines Hub which
is part of a national programme to transform aseptic services in England.
WYAAT has been identified as a pathfinder site for the programme which will
oversee the implementation and operation of a new aseptic facility to supply
large volumes of injectable medicines to WYAAT organisations. It's an
exciting time to join our supportive and dynamic team to deliver real change
and to make a difference to patient care.
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 have the following duties /
areas of responsibilities:
Ensures aseptic batch manufacture
is carried out efficiently and responsively and in compliance with current
legislation and standards and the principles of Good Manufacturing Practice.
Ensure equipment and facilities are
regularly maintained, inspected and any deficiencies dealt with promptly,
this includes oversight of validation and monitoring activities.
Manages the Production Specialists
/ Pharmacy Technicians.
Act as a professional role model
for direct reports and wider department
Supports the Production Manager in
the development and planning of the service.
Supports the Production Manager to
investigate and implement actions from errors and incidents and response to
audits, this can be complex required advanced skills relating to analysis and
interpretation of data and information
Contributes to service development
and supports effective change management within their own team and across all
of Pharmacy Preparative Services.
Ensures that agreed stock control
procedures are in place and followed.
Ensures (in liaison with QA/QC
team) that the following are undertaken.
Physical and Environmental
Monitoring
Operator and Process Validation
Lead team of technical and support
staff in the Production Manufacturing Unit 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 recruitment and
selection of technical and support staff.
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.
Provide operational support to the
service, including sessional supervision and accuracy checking. This will
usually be on a planned basis.
Responsible the management of the
weekend and bank holiday rota for preparative staff.
Always maintain high professional
standards and ensure compliance with statutory regulations concerning
pharmaceuticals and the provision of Health and Safety at work are complied
with.
Work with Production Management
Team in developing capacity and contingency plan for Production Manufacturing
Unit. This can be complex as several variable factors such as demand, the
availability of stock, staff competency levels and physical resource (e.g.,
isolators) must be taken into consideration and can change at short notice.
Maintain and develop statistical
data for performance monitoring of the Production Manufacturing Unit.
The post holder will analyse
performance and productivity reports for their team and use this to influence
change and contribute to improvements across the service.
Promote the cost-effective use of
equipment and supplies and to ensure that appropriate ordering and costing
procedures are in place.
Key member of the Production
Management team for the Trust, contributing to planning and development of
the Production Manufacturing Unit.
Participate in regular internal
audits of the service and take action to remedy and deficiencies to
continually improve the quality of the service.
Works with Advanced Production
Specialist Education and Training in ensuring the delivery of training and
competency assessments for staff working within the aseptic service,
including supporting the assessment of NVQ candidates.
Contribute to pharmacy service
developments and ensure that change is managed smoothly in relation to area
of responsibility.
Identify and in conjunction with
Production Management team implement risk reduction strategies in aseptic
dispensaries.
Develop 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.
This post holder will have a close working relationship with the Quality
Assurance Team.
Job description
Job responsibilities
This post will have the following duties /
areas of responsibilities:
Ensures aseptic batch manufacture
is carried out efficiently and responsively and in compliance with current
legislation and standards and the principles of Good Manufacturing Practice.
Ensure equipment and facilities are
regularly maintained, inspected and any deficiencies dealt with promptly,
this includes oversight of validation and monitoring activities.
Manages the Production Specialists
/ Pharmacy Technicians.
Act as a professional role model
for direct reports and wider department
Supports the Production Manager in
the development and planning of the service.
Supports the Production Manager to
investigate and implement actions from errors and incidents and response to
audits, this can be complex required advanced skills relating to analysis and
interpretation of data and information
Contributes to service development
and supports effective change management within their own team and across all
of Pharmacy Preparative Services.
Ensures that agreed stock control
procedures are in place and followed.
Ensures (in liaison with QA/QC
team) that the following are undertaken.
Physical and Environmental
Monitoring
Operator and Process Validation
Lead team of technical and support
staff in the Production Manufacturing Unit 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 recruitment and
selection of technical and support staff.
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.
Provide operational support to the
service, including sessional supervision and accuracy checking. This will
usually be on a planned basis.
Responsible the management of the
weekend and bank holiday rota for preparative staff.
Always maintain high professional
standards and ensure compliance with statutory regulations concerning
pharmaceuticals and the provision of Health and Safety at work are complied
with.
Work with Production Management
Team in developing capacity and contingency plan for Production Manufacturing
Unit. This can be complex as several variable factors such as demand, the
availability of stock, staff competency levels and physical resource (e.g.,
isolators) must be taken into consideration and can change at short notice.
Maintain and develop statistical
data for performance monitoring of the Production Manufacturing Unit.
The post holder will analyse
performance and productivity reports for their team and use this to influence
change and contribute to improvements across the service.
Promote the cost-effective use of
equipment and supplies and to ensure that appropriate ordering and costing
procedures are in place.
Key member of the Production
Management team for the Trust, contributing to planning and development of
the Production Manufacturing Unit.
Participate in regular internal
audits of the service and take action to remedy and deficiencies to
continually improve the quality of the service.
Works with Advanced Production
Specialist Education and Training in ensuring the delivery of training and
competency assessments for staff working within the aseptic service,
including supporting the assessment of NVQ candidates.
Contribute to pharmacy service
developments and ensure that change is managed smoothly in relation to area
of responsibility.
Identify and in conjunction with
Production Management team implement risk reduction strategies in aseptic
dispensaries.
Develop 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.
This post holder will have a close working relationship with the Quality
Assurance Team.
Person Specification
Qualifications
Essential
- BTEC in pharmaceutical science or NVQ level 3 in pharmacy services or Science Manufacturing or Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology or similar discipline
- BTEC/Certificate in Aseptic Dispensing or Quality Assurance or equivalent
- Aseptic preparation / manufacture and Good Manufacturing practice
Desirable
- Management / training / education qualification or evidence of formal management training
Experience
Essential
- Significant experience of Pharmaceutical Manufacturing / preparation of aseptic medicines and leading a pharmaceutical workforce.
- Substantial post qualification experience of hospital pharmacy, including at specialist pharmacy technician team leader level and comprehensive experience in aseptic dispensing / processing
Desirable
- Developing and implementation of procedures
- Development of risk assessments
Skills & behaviours
Essential
- Commitment to high standards of service delivery
Person Specification
Qualifications
Essential
- BTEC in pharmaceutical science or NVQ level 3 in pharmacy services or Science Manufacturing or Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology or similar discipline
- BTEC/Certificate in Aseptic Dispensing or Quality Assurance or equivalent
- Aseptic preparation / manufacture and Good Manufacturing practice
Desirable
- Management / training / education qualification or evidence of formal management training
Experience
Essential
- Significant experience of Pharmaceutical Manufacturing / preparation of aseptic medicines and leading a pharmaceutical workforce.
- Substantial post qualification experience of hospital pharmacy, including at specialist pharmacy technician team leader level and comprehensive experience in aseptic dispensing / processing
Desirable
- Developing and implementation of procedures
- Development of risk assessments
Skills & behaviours
Essential
- Commitment to high standards of service delivery
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).
