Senior Aseptic services Pharmacist - ATMPs, Clinical Trials and CIVAS
Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup.St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it.Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’.Our adult community services achieved a rating of ‘outstanding’.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS.We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.
Job overview
Senior Aseptic Services Pharmacist – ATMPs, Clinical Trials & CIVAS
Are you a skilled and motivated pharmacist looking to advance your career in aseptic services? We are seeking an enthusiastic Senior Aseptic Services Pharmacist to join our team at Guy’s and St Thomas’. This role offers a unique opportunity to contribute to the aseptic preparation of Advanced Therapy Medicinal Products (ATMPs), clinical trials, and CIVAS while ensuring the highest standards of quality and regulatory compliance.
As a key member of our aseptic services team, you will bring experience as an authorised pharmacist with a strong understanding of operational, quality, and regulatory requirements within an aseptic preparation unit. Working closely with and deputizing for the Accountable Pharmacist, you will play a vital role in ensuring the correct preparation of both existing and novel products, as well as overseeing staff training and compliance.
This is an exciting time to join us, as we expand aseptic services across multiple sites. The successful candidate will have the opportunity to work flexibly across different locations, contributing their expertise to cutting-edge pharmaceutical developments.A solid grasp of contamination control, risk assessment, and regulatory frameworks will be key to excelling in this role.
If you’re passionate about innovation in aseptic services and want to be part of a forward-thinking team, we’d love to hear from you!
Main duties of the job- To be the deputy accountable pharmacist in the leadership and delivery of aseptic service for Guy’s site aseptic preparation of advanced therapies, clinical trials and CIVAS. To work flexibly on either site in response to service review and changes.
- To be responsible for ensuring the requirements of the aseptic unit’s quality management system are maintained as required by Quality Assurance of Aseptic Preparation Services (QAAPS) and other NHS guidance.
- To lead and be responsible for the set up and delivery of aseptic services to support new products and clinical trials for GSTT and commercial sponsored trials to ensure full manufacturing and clinical regulatory compliance.
Working for our organisation
Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS Foundation Trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopedic, respiratory and cardiovascular services.
Guy's & St Thomas' Technical Services is a large licensed and section 10 manufacturing unit with a wide product portfolio, including terminally sterilised and non-sterile manufacturing, as well as a variety of extemporaneously prepared aseptic and non-sterile dosage forms.
Aseptic services are currently based on the Guy's and St Thomas' sites with new and upgraded facilities on the St Thomas' site and a recently recommissioned aseptic containment suite on the Guy's site.
Pharmacy Technical Services employs over 100 staff in multiple areas across the Guy's and St Thomas' sites.
Detailed job description and main responsibilities
Key areas of role performance - see job description for details:
Quality and Service management
Service evaluation and development
New products and clinical trials
Person specification
Skills
Essential criteria- Demonstrated practical knowledge of GCP, GMP, QA as required to ensure compliance of aseptic preparation of medicines.
- Demonstrated ability to undertake risk and impact assessments, investigations, root cause analysis and developing action plans for out of specification results and process deviations within the context of an aseptic quality system
- Be able to demonstrate a practical understand of the requirements for an effective contamination control strategy for an aseptic preparation services and how this should be developed.
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products.
- Demonstrated evidence of being able to manage change with production services
Experience
Essential criteria- Previous assessable experience of supervising operations and undertaking aseptic product release in an unlicensed aseptic unit with a comprehensive portfolio of aseptic products.
- Previous evaluated experience of managing the introduction, operation and audit of IMPs requiring aseptic preparation according to GMP and GCP
- Previous assessable experience of managing workload and capacity to ensure safe working levels
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits
Qualifications
Essential criteria- Pharmacy degree or Masters degree in science based discipline
- Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge
Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Flexible working
We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personal circumstances as well the needs of the service.We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.
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