Job summary
We have an opportunity for you to become part of our Quality Assurance department as a 12 month secondment.
It is an exciting time as we are an enthusiastic and dynamic team who put patients at
the centre of everything we do. The Aseptic unit is a section 10 unlicensed unit who produce parenteral nutrition, chemotherapy, immunotherapy and CIVAs to all sites within the Mid Yorkshire Teaching hospitals.
You will be responsible for the management of our Pharmaceutical Quality Management System and lead a small QA team who work closely with aseptic services.
If you have relevant experience and would like this opportunity, please speak to: Tracey Keys- Lead Pharmacist- Aseptic Services.
Main duties of the job
The main duties of this role is to ensure that the Pharmacy Aseptic Service produces high quality products in line
with all relevant standards and procedures, minimising risk to patients and
healthcare professionals.
To
maximise the effectiveness and influence of the Pharmaceutical Quality System
(PQS) in all preparation areas within pharmacy aseptics and department wide.
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:
Perform a range of highly specialist activities
including management and coordination of the PQS.
Utilising highly specialist knowledge to
perform, and support co-ordination of, research innovation and continuous
improvement within the Pharmacy Aseptic Service.
Provide highly specialist advice and guidance to
the Pharmacy Aseptic Service and the wider pharmacy department.
Co-ordinate and develop, with training leads for
respective sites, highly specialist training to the Aseptic Service Unit (ASU) workforce
for quality-related activities.
Assess
the suitability of Unlicensed Medicines purchased by the Trust, providing
advice on quality and safety to prescribers and procurement and medicines
information leads.
Manage the validation of facilities, equipment
and processes within Pharmacy Aseptic Services.
About us
We provide care and support to over a million people in
Wakefield and Kirklees in their homes, community settings and across our
three hospital sites at Pontefract, Dewsbury and Pinderfields (Wakefield).
Always striving for excellence, we are at the forefront of
innovation and research, and we invest in teaching and the development of our
workforce.
We live by our values of caring, improving, being respectful
and maintaining high standards. We listen and learn because we aim to make Mid
Yorkshire the best place to work and receive care.
We value diversity and welcome talent and enthusiasm
irrespective of age, disability, neurodivergence, sex, gender identity and
gender expression, race or ethnicity, religion or belief, sexual orientation,
or other personal circumstances including providing unpaid carers support to
someone with a health and care need. As ethnic minority groups, members of the
LGBTQ+ community, and people with a disability/neurodivergence are currently
under-represented across the organisation, we encourage applications from
members of these groups. We have policies and procedures to ensure all
applicants are treated fairly and consistently.
We are proud of our staff networks - who offer valuable
guidance and feedback from those with lived experience.
We have a clear vision and you could be part of this! If
you share our values and you want to make a difference to the lives of our
patients and their families and carers, we would love to hear from you.
Job description
Job responsibilities
Quality Assurance/Quality Control
1. Plan and implement a schedule of environmental monitoring (both physical and microbiological) for the ASU and report on compliance with national standards, liaising closely with Specialist Technicians and the Lead Pharmacist. Provide detailed and highly specialised reports on testing to the Lead Pharmacist, Aseptic Services and Facilities and Maintenance (FM) Provider, currently Equans.
2. Participate in and oversee the physical monitoring programme, operating specialised equipment.
3. Act as System Manager for the Microbiological Reporting System (MRS) used to collate and trend data from monitoring of the aseptic suite. Develop trending tools using software applications.
4. Assist in establishing and maintaining stability data files to support shelf lives and storage conditions assigned to each product prepared in pharmacy.
5. Develop Pharmacy QA/QC services to meet the changing demands of the Trust and external regulators (MHRA and Regional Quality Assurance Leads).
6. Develop, set and monitor systems to collect, collate and present information on QA/QC for performance management and benchmarking purposes.
7. Responsibility for the development and maintenance of a trust-wide temperature monitoring system within the pharmacy department to monitor drug temperature storage, including Clinical Trials. Advise on temperature excursions.
8. Participate in the preparation of Technical/ Service Level Agreements for contracted work such as specialised microbiological identification and clean room testing.
9. Approve, with the Lead Pharmacist - Technical Services, all Standard Operating Procedures (SOPs) used in the Aseptic Services Unit.
10. Maintain, update and approve the QA procedure manual which defines all the Quality Control and Assurance Procedures used within the QA department. This will include the development of a PQS within the laboratory and the preparation and approval of all controlled documents and policies within the QA department.
11. Ensure that monitoring is carried out and recorded in accordance with the requirements of EU GMP, QAAPS and ISO 16444.
12. Develop and implement a system to ensure that the purchase and issue of Unlicensed Medicines are fully controlled and documented as defined in Medicines & Healthcare products Regulatory Agency (MHRA) and National QA guidance.
13. Develop and co-ordinate in conjunction with the Lead Pharmacist an on-going programme of aseptic process validation as required by national standards.
14. Maintain calibration schedules for all QA test instruments and equipment.
a. Receive and investigate medicinal product complaints and defects. This will involve liaising with suppliers to rectify the defect or arrange replacement / reimbursement and providing feedback to complainants. Feedback will also be submitted to a National QA defects database and the MHRA if necessary.
b. Provide advice on Quality Assurance systems to Managers of other Departments in the Trust when required e.g. HSDU. Provide complex reports on microbiological monitoring and room classifications to HSDU managers.
c. Ensure that all maintenance and re-validation work carried out by contractors is performed to National Standards by assessment of method statements or witnessing testing and that any reports issued as a result of this work are appropriately detailed. Provide specialist advice on the purchase of new equipment and facilities in Aseptic Services, liaising with departmental leads, service managers and budget holders where necessary.
Job description
Job responsibilities
Quality Assurance/Quality Control
1. Plan and implement a schedule of environmental monitoring (both physical and microbiological) for the ASU and report on compliance with national standards, liaising closely with Specialist Technicians and the Lead Pharmacist. Provide detailed and highly specialised reports on testing to the Lead Pharmacist, Aseptic Services and Facilities and Maintenance (FM) Provider, currently Equans.
2. Participate in and oversee the physical monitoring programme, operating specialised equipment.
3. Act as System Manager for the Microbiological Reporting System (MRS) used to collate and trend data from monitoring of the aseptic suite. Develop trending tools using software applications.
4. Assist in establishing and maintaining stability data files to support shelf lives and storage conditions assigned to each product prepared in pharmacy.
5. Develop Pharmacy QA/QC services to meet the changing demands of the Trust and external regulators (MHRA and Regional Quality Assurance Leads).
6. Develop, set and monitor systems to collect, collate and present information on QA/QC for performance management and benchmarking purposes.
7. Responsibility for the development and maintenance of a trust-wide temperature monitoring system within the pharmacy department to monitor drug temperature storage, including Clinical Trials. Advise on temperature excursions.
8. Participate in the preparation of Technical/ Service Level Agreements for contracted work such as specialised microbiological identification and clean room testing.
9. Approve, with the Lead Pharmacist - Technical Services, all Standard Operating Procedures (SOPs) used in the Aseptic Services Unit.
10. Maintain, update and approve the QA procedure manual which defines all the Quality Control and Assurance Procedures used within the QA department. This will include the development of a PQS within the laboratory and the preparation and approval of all controlled documents and policies within the QA department.
11. Ensure that monitoring is carried out and recorded in accordance with the requirements of EU GMP, QAAPS and ISO 16444.
12. Develop and implement a system to ensure that the purchase and issue of Unlicensed Medicines are fully controlled and documented as defined in Medicines & Healthcare products Regulatory Agency (MHRA) and National QA guidance.
13. Develop and co-ordinate in conjunction with the Lead Pharmacist an on-going programme of aseptic process validation as required by national standards.
14. Maintain calibration schedules for all QA test instruments and equipment.
a. Receive and investigate medicinal product complaints and defects. This will involve liaising with suppliers to rectify the defect or arrange replacement / reimbursement and providing feedback to complainants. Feedback will also be submitted to a National QA defects database and the MHRA if necessary.
b. Provide advice on Quality Assurance systems to Managers of other Departments in the Trust when required e.g. HSDU. Provide complex reports on microbiological monitoring and room classifications to HSDU managers.
c. Ensure that all maintenance and re-validation work carried out by contractors is performed to National Standards by assessment of method statements or witnessing testing and that any reports issued as a result of this work are appropriately detailed. Provide specialist advice on the purchase of new equipment and facilities in Aseptic Services, liaising with departmental leads, service managers and budget holders where necessary.
Person Specification
Experience
Essential
- Significant post qualification experience.
- Experience of working in the NHS (including hospital Pharmacy).
- Line management experience.
- Training of other staff.
- GMP and Aseptic preparation.
Desirable
- Experience in pharmaceutical microbiology.
Qualifications
Essential
- Registered with General Pharmaceutical Council (GPhC) as a Pharmacy Technician.
- Or significant demonstrable experience of working as a QA Specialist/Officer.
- Or
- Degree in a science-based subject e.g. Pharmacy, Chemistry, Microbiology or significant experience in all aspects of Pharmaceutical Quality Assurance.
- Willing to work towards post-graduate diploma in Pharmaceutical Technology and Quality Assurance (PTQA).
Desirable
- Post Graduate Management Qualification to diploma level (or equivalent experience).
Training
Essential
- Relevant training in Quality Assurance.
- Portfolio of evidence for on-going continuing education & professional development (CPD).
- Evidence of personal development.
- Continued commitment to improve skills and ability in new areas of work.
Desirable
- Formal in-depth training in pharmaceutical quality assurance.
Knowledge and Awareness
Essential
- Highly detailed understanding of the regulations relating to the Medicines Act, Good Manufacturing Practice (GMP), MHRA legislation, to include in-depth knowledge of pharmaceutical GMP and national NHS standards, including the standards required by Quality Assurance of Aseptic preparation Services (QAAPS) against which the department is audited by external experts.
- An in-depth awareness of current Quality Management Systems.
- Detailed knowledge of the internal and external audit process, change control, document control, validation and CA/PA.
Person Specification
Experience
Essential
- Significant post qualification experience.
- Experience of working in the NHS (including hospital Pharmacy).
- Line management experience.
- Training of other staff.
- GMP and Aseptic preparation.
Desirable
- Experience in pharmaceutical microbiology.
Qualifications
Essential
- Registered with General Pharmaceutical Council (GPhC) as a Pharmacy Technician.
- Or significant demonstrable experience of working as a QA Specialist/Officer.
- Or
- Degree in a science-based subject e.g. Pharmacy, Chemistry, Microbiology or significant experience in all aspects of Pharmaceutical Quality Assurance.
- Willing to work towards post-graduate diploma in Pharmaceutical Technology and Quality Assurance (PTQA).
Desirable
- Post Graduate Management Qualification to diploma level (or equivalent experience).
Training
Essential
- Relevant training in Quality Assurance.
- Portfolio of evidence for on-going continuing education & professional development (CPD).
- Evidence of personal development.
- Continued commitment to improve skills and ability in new areas of work.
Desirable
- Formal in-depth training in pharmaceutical quality assurance.
Knowledge and Awareness
Essential
- Highly detailed understanding of the regulations relating to the Medicines Act, Good Manufacturing Practice (GMP), MHRA legislation, to include in-depth knowledge of pharmaceutical GMP and national NHS standards, including the standards required by Quality Assurance of Aseptic preparation Services (QAAPS) against which the department is audited by external experts.
- An in-depth awareness of current Quality Management Systems.
- Detailed knowledge of the internal and external audit process, change control, document control, validation and CA/PA.
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.
