Quality Assurance Specialist
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
Pharmaceutical Quality Assurance Specialist
We are looking for two excellent and motivated quality professionals to join our Quality Team based multisite at Guys and St Thomas'. Ideally you will have experience working in the pharmaceutical industry or NHS in quality assurance.
The successful candidates will be working with our licensed and unlicensed units so experience within these areas is key. We currently are looking to recruit to a permanent position within our licensed units and a fixed term (maternity cover) position within our unlicensed units.
The posts provide an excellent opportunity for healthcare scientists who have been through the STP programme and are currently working in a foundation quality position.
Working with us provides excellent opportunities to utilise your GMP and Quality knowledge, skills and experience and prepare you for more senior roles leading on projects and staff management opportunities.
The QA department supports a variety of areas across the hospital trust and there is an opportunity to work with a wide variety of teams across multiple disciplines.
This opportunity provides excellent foundations and experience for any candidate thinking of progressing within Quality Assurance in the future with the opportunity to work alongside experienced quality professionals.
Main duties of the job- To lead and deliver Pharmaceutical QA Services to the Trust Pharmacy Manufacturing and Quality Control Units.
- To be responsible for maintaining the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the MS, MA(IMP) licences and NHS guidance.
- To provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.
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, orthopaedic, 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, aseptically manufactured and non-sterile products, as well as a variety of extemporaneously prepared aseptic and non-sterile dosage forms.Pharmacy Technical Services employs over 100 staff in multiple areas across the Guy's and St Thomas' sites.
Pharmacy Quality Assurance provides QA support to a number of facilities across both the Guy's and St Thomas' sites, including the MS licensed Aseptic, Sterile and Non-sterile Units and also unlicensed units (CIVAS/TPN and Oncology) and the main Pharmacy.
Detailed job description and main responsibilities
Service management- To ensure that the pharmaceutical quality management system is maintained and developed in accordance with the MS and MA(IMP) licence requirements and in response to changes in regulations and legislation.
- To provide senior QA input into complex quality exceptions to ensure satisfactory corrective and preventative action is taken. To undertake a regular senior QA review of all quality exceptions according to department procedures.
- To ensure all changes to the quality management system are effectively communicated via the change control process to all grades of staff. By example and effective communication to create an environment of quality improvement.
- To carry out Trust GMP Internal Audits.
- To ensure the Internal Audit Programme is adhered to and audits are reported and actioned in a timely manner.
- To review and update all QA documentation as required in accordance with GMP
- To maintain and develop the documentation control system in accordance with GMP.
- To be responsible for ensuring that all the QA requirements for the validation master plan are fully completed and documented.
- To provide QA service to other NHS Production units in accordance with licences and Technical Agreements/Service Contracts.
- To review and coordinate the service contracts and technical agreements with suppliers.
- To coordinate the documentation, sample collection and results reporting for the microbiological testing service.
- To respond to customer complaints and undertake drug defect investigation for Trust manufactured products.
- To report drug defects on purchased products to manufacturer’s and communicate response to end user.
- To coordinate the Trust response to Drug Alerts issued by the MHRA.
- To supervise the work of the Technical / Clinical Interface Pharmacists (Band 7) and QA Officers B6/7, to ensure that all activities undertaken within the unit meet current legislation such as GMP/GDP, GCP, Health and Safety, COSHH, and that all work documentation and procedures meet these regulations.
- To supervise the work of the Microbiological Team to ensure that all environmental monitoring of the manufacturing areas is carried out routinely and results reported efficiently in accordance with GMP.
- To ensure that all staff working in the QA department are trained and competency assessed in the tasks they undertake.
- To ensure there is sufficient QA cover to undertake all monitoring and release activities. To report any deficiencies to the Deputy QA Manager and the Head of Pharmaceutical Quality as appropriate.
- To be responsible for the recruitment and selection process for staff within the QA department.
- To be responsible for the maintenance of the training records for all staff in the QA department.
- To participate in the training of pharmacists technicians, and scientists with the QA department and externally to the trust as necessary.
- To critical assess the current quality management systems with a view to maintaining a continuous quality improvement cycle within the department.
- To be responsible for updating and enhancing current unit documentation in line with accepted guidelines and changes in the workings of the QA department. To ensure changes are documented and controlled following department procedures.
- To attend regulatory and internal audits and meet the requirements of the auditor in a clear and concise manner. To lead on the response to audit deficiencies and ensure agreed action plans are completed in a timely manner.
- To be responsible for the planning and introduction of new documents to manage and monitor developments within the QA department.
- To undertake risk assessment activities within the Trust to identify high risk activities that could be managed within the resources of the QA department.
- To assist in other practice research and in service development in accordance with jointly agreed objectives between the post holder and Deputy QA Manager/Head of Pharmaceutical Quality.
- To review new trials requiring QA services to ensure that the protocol, authorisation and ethical approval meets the requirements of The Medicines for Human Use (Clinical Trial) Regulations 2004.
- To review new trial documentation and assess the quality requirements for new clinical trials to be made under the Section 10 exemption. To ensure that all clinical trial production follows the principles of GMP and GCP and follows the department's quality management system.
- To review and authorise all clinical trial production documentation to ensure the preparation of the clinical trials complies with all regulatory requirements.
- To attend site visits and audits by sponsors, clinical research organisations and their representatives to ensure that all pharmacy requirements for the undertaking of IMP production are available.
- To lead in the response to audit deficiencies in a timely manner as required.
- To provide QA support to the development, formulation and validation of new products in response to clinical need and risk management in accordance with objectives set by the Product Lifecycle Team
- To provide the QA input to ensure the key objectives within the validation master plan for pharmacy manufacturing are met.
- To support and where required supervise designated MPharm/MPhil./PhD/STP students registered with the Universities and to ensure that agreed standards and systems of work are followed
- To provide expert pharmaceutical QA advice on the use of all other products prepared by the Licensed Units.
- To respond to MHRA Drug Alerts and coordinate the retrieval, quarantine and replacement of stock.
- To lead on the documentation and communication of Drug Alerts to all relevant areas of the Trust.
Person specification
Skills
Essential criteria- Demonstrated practical knowledge of GMP, QA, risk management and all current relevant regulations.
- Demonstrated ability to identify and manage risks.
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
- Demonstrated computer and IT skills including databases & pharmacy specific systems for building and managing products’
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products.
- Ability to work on own, to direct and plan one’s own work
Experience
Essential criteria- Previous evaluated experience working as a releasing officer in a licenced/unlicensed pharmaceutical production unit with a comprehensive portfolio of products.
- Experience of quality systems and documentation management systems
- Previous evaluated experience of QA involvement in the management of clinical trials according to GMP and GCP.
- Previous evaluated experience of developing and expanding QA services
- 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
- Member of professional society/institution (Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society)
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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