Job summary
Liverpool University Hospitals NHS Foundation Trust
Quality Management and Assurance Lead
Pharmacy Aseptic Services -Aseptic Production Unit
Band 8B (37.5 hours per week)
We are a major acute teaching Trust offering a wide range of clinical specialities, including tertiary referrals for HIV and Renal Medicine. Pharmacy services are well developed and deliver high quality Medicines Management.
We have a highly regarded Aseptic Production Unit (APU) at the Trust with a brand-new Manufacturing site licensed in June 2023. You will work closely with our Aseptic Service Leads to help steer the quality facilitating programmes at the Manufacturing Site. You will manage and lead projects of work relating to the development and implementation of quality systems, allowing for safe and efficient delivery of medicines manufactured at the Site.
With a focus on 'Quality related matters', you will be responsible for ensuring that all the supporting structures embedded, allow for outputs that align and deliver to the manufacturing sites Pharmaceutical Quality System.
With significant experience of pharmaceutical quality management, the post holder will be capable of working under pressure, prioritising to deadlines and multi-tasking.
For further information please contact Shakeel Herwitker, (Head of Manufacturing Services) Pharmacy Aseptic Services on 0151 706 2454,
e-mail Shakeel.Herwitker@liverpoolft.nhs.uk
Main duties of the job
To ensure the delivery of safe and effective pharmaceutical products (medicines), fit for its intended use.
To drive, support and embed the development of a quality facilitating system that ensures safe and effective operation of the manufacturing site.
To ensure that all pharmaceutical production activities at the manufacturing site comply with current regulations and applicable standards.
About us
Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University Hospital NHS Foundation Trust and the Royal Liverpool and Broadgreen University Hospitals NHS Trust.
The merger provides an opportunity to reconfigure services in a way that provides the best healthcare services to the city and improves the quality of care and health outcomes that patients experience.
The Trust runs Aintree University Hospital, Broadgreen Hospital, Liverpool University Dental Hospital and the Royal Liverpool University Hospital.
It serves a core population of around 630,000 people across Merseyside as well as providing a range of highly specialist services to a catchment area of more than two million people in the North West region and beyond.
To hear more about our achievements click here https://www.liverpoolft.nhs.uk/media/13089/1606-annual-report-booklet_final.pdf
Follow us on Social Media:
Facebook - Liverpool University Hospitals Careers
Instagram - @LUHFTcareers
Twitter - @LUHFTcareers
Job description
Job responsibilities
Lead the development, delivery and maintenance of the Quality Management and Assurance Systems to enable the operation of a safe, effective pharmacy Aseptic Production Unit (APU).
Ensure relevant regulatory standards are met, with regard for Good Manufacturing Practice (GMP) activities and achievement and maintenance of relevant licenses e.g., MHRA license.
The post holder will support the Head of Manufacturing Services and the Head of Quality Assurance with assessing and implementing the quality related aspects as applicable to the APU when considering facilities, business development initiatives, and customer service models.
Be named as Quality Controller on the Aseptic Production Unit (APU) - MS and MIA (IMP) License and undertake all necessary duties associated with the role.
Advise and guide the pharmacy team with regards to clinical trials regulatory affairs as relevant to the development, production & release of Investigational Medicinal Products (IMPs). Oversee trials activities within the APU, including liaison with Trust R&D Team and the manufacturing site production team.
Job description
Job responsibilities
Lead the development, delivery and maintenance of the Quality Management and Assurance Systems to enable the operation of a safe, effective pharmacy Aseptic Production Unit (APU).
Ensure relevant regulatory standards are met, with regard for Good Manufacturing Practice (GMP) activities and achievement and maintenance of relevant licenses e.g., MHRA license.
The post holder will support the Head of Manufacturing Services and the Head of Quality Assurance with assessing and implementing the quality related aspects as applicable to the APU when considering facilities, business development initiatives, and customer service models.
Be named as Quality Controller on the Aseptic Production Unit (APU) - MS and MIA (IMP) License and undertake all necessary duties associated with the role.
Advise and guide the pharmacy team with regards to clinical trials regulatory affairs as relevant to the development, production & release of Investigational Medicinal Products (IMPs). Oversee trials activities within the APU, including liaison with Trust R&D Team and the manufacturing site production team.
Person Specification
Qualifications
Essential
- Vocational Masters Degree in Pharmacy or equivalent qualification with another body.
- Post-graduate pharmacy qualification (PTQA qualifications satisfying the MHRA for naming as the Quality Controller on the MS License).
Desirable
- Leadership / management qualification/training or equivalent experiential learning.
Experience
Essential
- Significant Hospital experience in both clinical & technical services.
- Significant Experience of Preparation & Manufacture inclusive of Clinical Trials.
- Service/ personnel management/ supervision.
- Evidence of significant, relevant and on-going personal CPD.
Desirable
- Experience of managing others including appraisals, objective setting and personal development planning.
- Experience of working across organizational boundaries and managing complex stakeholder relationships.
- Experience of Pharmaceutical Manufacture in either a hospital or industrial environment or previous experience of managing aseptic dispensing services.
Knowledge
Essential
- Detailed knowledge of Good Manufacturing Practice and the regulations surrounding Pharmaceutical Manufacture.
- Knowledge of legal requirements associated with the provision of aseptically dispensed and manufactured 'specials'.
- Knowledge of clean room design and functioning.
- Evidence of strategic planning/ service development experience.
- Evidence of workforce development.
Desirable
- Expert knowledge of risk management systems and processes.
- Expert knowledge of medicines legislation and regulation within NHS acute trust settings.
- Specialist knowledge of Pharmaceutical Manufacturing Processes including equipment and facility design, construction, validation and testing.
- Significant Knowledge of:- o Aseptic preparation of medicines. o Terminal Sterilization processes.
- An understanding of medicines management procedures.
- Knowledge of product licensing and medical devices registration.
Skills
Essential
- Ability to work effectively as part of a team or to work alone without direct supervision when required.
- Able to direct team activity and facilitate staff development.
- Ability to work to deadlines and meet targets.
- Good time management and organizational skills, ability to prioritize effectively.
- Able to prioritize own workload and for others.
- Good leadership and management skills.
- Ability to affect and manage change successfully.
- Ability to work under pressure with constant interruption whilst maintaining attention to detail and accuracy.
- Ability to use Microsoft Office applications. e.g. Word, Excel, Outlook and advanced literature searching.
- Excellent communication and negotiation skills with other professionals, patients and carers, including verbal, written and electronic.
- Good interpersonal skills, able to work with all grades of staff, patients and the public.
- Ability to critically reflect on own and teams performance.
- Ability to remain calm and articulate in contentious situations.
- Approachable, able to motivate and engage stakeholders and team in the end vision.
- Able to think innovatively and creatively when faced with a problem.
- Passionate about improving services for patients, staff & customers.
- Enthusiastic with ability to motivate self and others.
- Conscientious and reliable.
- Methodical with attention to detail.
Person Specification
Qualifications
Essential
- Vocational Masters Degree in Pharmacy or equivalent qualification with another body.
- Post-graduate pharmacy qualification (PTQA qualifications satisfying the MHRA for naming as the Quality Controller on the MS License).
Desirable
- Leadership / management qualification/training or equivalent experiential learning.
Experience
Essential
- Significant Hospital experience in both clinical & technical services.
- Significant Experience of Preparation & Manufacture inclusive of Clinical Trials.
- Service/ personnel management/ supervision.
- Evidence of significant, relevant and on-going personal CPD.
Desirable
- Experience of managing others including appraisals, objective setting and personal development planning.
- Experience of working across organizational boundaries and managing complex stakeholder relationships.
- Experience of Pharmaceutical Manufacture in either a hospital or industrial environment or previous experience of managing aseptic dispensing services.
Knowledge
Essential
- Detailed knowledge of Good Manufacturing Practice and the regulations surrounding Pharmaceutical Manufacture.
- Knowledge of legal requirements associated with the provision of aseptically dispensed and manufactured 'specials'.
- Knowledge of clean room design and functioning.
- Evidence of strategic planning/ service development experience.
- Evidence of workforce development.
Desirable
- Expert knowledge of risk management systems and processes.
- Expert knowledge of medicines legislation and regulation within NHS acute trust settings.
- Specialist knowledge of Pharmaceutical Manufacturing Processes including equipment and facility design, construction, validation and testing.
- Significant Knowledge of:- o Aseptic preparation of medicines. o Terminal Sterilization processes.
- An understanding of medicines management procedures.
- Knowledge of product licensing and medical devices registration.
Skills
Essential
- Ability to work effectively as part of a team or to work alone without direct supervision when required.
- Able to direct team activity and facilitate staff development.
- Ability to work to deadlines and meet targets.
- Good time management and organizational skills, ability to prioritize effectively.
- Able to prioritize own workload and for others.
- Good leadership and management skills.
- Ability to affect and manage change successfully.
- Ability to work under pressure with constant interruption whilst maintaining attention to detail and accuracy.
- Ability to use Microsoft Office applications. e.g. Word, Excel, Outlook and advanced literature searching.
- Excellent communication and negotiation skills with other professionals, patients and carers, including verbal, written and electronic.
- Good interpersonal skills, able to work with all grades of staff, patients and the public.
- Ability to critically reflect on own and teams performance.
- Ability to remain calm and articulate in contentious situations.
- Approachable, able to motivate and engage stakeholders and team in the end vision.
- Able to think innovatively and creatively when faced with a problem.
- Passionate about improving services for patients, staff & customers.
- Enthusiastic with ability to motivate self and others.
- Conscientious and reliable.
- Methodical with attention to detail.
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).
Employer details
Employer name
Liverpool University Hospitals NHS Foundation Trust
Address
Royal Liverpool University Hospital
Pharmacy, Level 2 – Clinical Support Services Building (CSSB), Mount Vernon street
Liverpool
L7 8YE
Employer's website
https://www.liverpoolft.nhs.uk/ (Opens in a new tab)
