Job summary
Are
you ready to embark on a journey where your passion for science and quality
management meets the forefront of patient care? At Leeds Teaching Hospitals
Trust, we're on a mission to revolutionise healthcare through our Aseptic
Services team.
You
will work as part of a large multi-disciplinary team who make a real
difference to patient care and clinical research by delivering a
comprehensive seven day service across the Trust. We produce over 50,000 chemotherapy items
each year along with a wide variety of other IV medicines such as CIVA
products, Parenteral Nutrition and Clinical Trials including many Phase-1
studies across our two aseptic units.
We're
looking for passionate, flexible quality management scientists who are driven
by a deep sense of purpose and a commitment to excellence to help oversee the
safe preparation of medicines in one of the UKs largest aseptics
departments. Join us in the journey of saving lives and shaping the future of
healthcare.
Main duties of the job
This
is a varied role working across both aseptic units (SJUH and LGI). The role
will see you completing many different tasks on a day-to-day basis, including
(but not limited to):
Assisting in the management of the
PQS to ensure compliance with relevant standards
Ensuring both aseptic units are
fully functional, and that appropriate SOPs are followed
Training junior staff in the
fundamentals of the PQS
Authoring and reviewing controlled
documents
Working with the Accountable
Pharmacist and other Scientists to complete the necessary work to ensure our
QMS is kept up-to-date
Working closely with the Advanced
Pharmaceutical Scientists to risk assess and investigate NCs and assist in
their close out using RCA tools
Ensuring our stringent cleaning and
environmental monitoring schedules are followed
As
the successful candidate, you must have excellent communication and
interpersonal skills, be self-motivated, be able to work on your own
initiative as well as working within a team.
About us
The
products we make arent a treatment theyre a lifeline for countless
individuals fighting chronic illnesses such as cancer. By joining our team,
you'll be part of a community of professionals who understand the immense
impact of what we do. Together, we'll work to ensure that each product is
prepared with the utmost precision and care, giving our patients the best
possible chance at beating their illness and reclaiming their lives. Every
day, you'll have the chance to make a difference in the lives of patients and
their families.
In
return for your dedication, we'll provide you with the training, development
opportunities, and resources you need to reach your full potential, all
taking place in a friendly, progressive department.
Join
a team of professionals who share your passion for excellence and your
commitment to patient care. You'll receive the support, mentorship, and
camaraderie you need to thrive and grow in your career.
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
JOB
PURPOSE
To
ensure that the MMPS preparative service produces high quality products in
line with all relevant standards and procedures, minimising risk to patients
and healthcare professionals. To focus on continuous improvement across the
preparative service with a specific focus on aseptic services and beyond.
To
maximise the effectiveness and influence of the Pharmaceutical Quality System
in all preparation areas within MMPS. This is to ensure that high risk
parenteral medicines are compounded and delivered in accordance with current
Good Manufacturing Practice (cGMP). This role will include a specific focus
on validation and re-validation of key processes, people and equipment across
the preparative service.
To
help manage a team of technical and support staff within preparative services
and to perform a key supervisory and leadership role of at weekends and Bank
Holidays.
JOB
DIMENSIONS
This
post will work closely with all areas across the MMPS Preparative Service,
one of the biggest of its type in the UK. The service consists of:
A
Pharmacy Manufacturing Unit at Moor House, consisting of a Dispensary Support
Unit (DSU) and Aseptic Production Unit (operating under a Specials licence
from the MHRA)
Two
large unlicensed Aseptic Dispensaries at St James Hospital and Leeds General
Infirmary (where this post will be based)
An
unlicensed Radiopharmacy Unit at St James Hospital
A
Quality Control/Quality Assurance Department at Moor House
The
post holder will work with the Accountable Pharmacist for Aseptic Services to
ensure that all unlicensed medicine preparation and distribution within the
aseptic units is carried out in accordance with standards specified in QAAPS
and cGMP.
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 Accountable Pharmacist 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
support for the Preparative Service Leadership team in the investigation and
actions from errors and incidents and response to audits.
Job description
Job responsibilities
JOB
PURPOSE
To
ensure that the MMPS preparative service produces high quality products in
line with all relevant standards and procedures, minimising risk to patients
and healthcare professionals. To focus on continuous improvement across the
preparative service with a specific focus on aseptic services and beyond.
To
maximise the effectiveness and influence of the Pharmaceutical Quality System
in all preparation areas within MMPS. This is to ensure that high risk
parenteral medicines are compounded and delivered in accordance with current
Good Manufacturing Practice (cGMP). This role will include a specific focus
on validation and re-validation of key processes, people and equipment across
the preparative service.
To
help manage a team of technical and support staff within preparative services
and to perform a key supervisory and leadership role of at weekends and Bank
Holidays.
JOB
DIMENSIONS
This
post will work closely with all areas across the MMPS Preparative Service,
one of the biggest of its type in the UK. The service consists of:
A
Pharmacy Manufacturing Unit at Moor House, consisting of a Dispensary Support
Unit (DSU) and Aseptic Production Unit (operating under a Specials licence
from the MHRA)
Two
large unlicensed Aseptic Dispensaries at St James Hospital and Leeds General
Infirmary (where this post will be based)
An
unlicensed Radiopharmacy Unit at St James Hospital
A
Quality Control/Quality Assurance Department at Moor House
The
post holder will work with the Accountable Pharmacist for Aseptic Services to
ensure that all unlicensed medicine preparation and distribution within the
aseptic units is carried out in accordance with standards specified in QAAPS
and cGMP.
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 Accountable Pharmacist 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
support for the Preparative Service Leadership team in the investigation and
actions from errors and incidents and response to audits.
Person Specification
Skills & Behaviours
Essential
- Flexible and adaptable
- Reliable
- Enthusiastic
- Positive mindset
- Excellent interpersonal skills
Desirable
- Experience of leadership and motivating staff
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post
Experience
Essential
- Experience of QMS and PQS
- Experience of checking other peoples work
- Understanding and experience of risk assessment and RCA tools
Desirable
- Specific experience within aseptic preparative services
- Knowledge of cleanroom design and functioning
- Experience within a scientific setting, i.e. laboratory or other production environment
- Experience of accuracy checking medicinal products
- Experience of training others
Qualifications
Essential
- Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, or related discipline
Desirable
- Post graduate certificate or diploma in relevant field
- Further education in Pharmacy Technical Services e.g. PTQA or STP
Person Specification
Skills & Behaviours
Essential
- Flexible and adaptable
- Reliable
- Enthusiastic
- Positive mindset
- Excellent interpersonal skills
Desirable
- Experience of leadership and motivating staff
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post
Experience
Essential
- Experience of QMS and PQS
- Experience of checking other peoples work
- Understanding and experience of risk assessment and RCA tools
Desirable
- Specific experience within aseptic preparative services
- Knowledge of cleanroom design and functioning
- Experience within a scientific setting, i.e. laboratory or other production environment
- Experience of accuracy checking medicinal products
- Experience of training others
Qualifications
Essential
- Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, or related discipline
Desirable
- Post graduate certificate or diploma in relevant field
- Further education in Pharmacy Technical Services e.g. PTQA or STP
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.
