Skip to main content
Please wait, loading

Job summary

Main area
Pharmacy Quality Assurance
Grade
NHS AfC: Band 7
Contract
Permanent
Hours
Full time - 37.5 hours per week
Job ref
196-LIS9978D
Employer
Guy's and St Thomas' NHS Foundation Trust
Employer type
NHS
Site
St Thomas' Hospital
Town
London
Salary
£56,276 - £63,176 p.a. inc HCA
Salary period
Yearly
Closing
09/11/2025 23:59

Employer heading

Guy's and St Thomas' NHS Foundation Trust logo

Senior Quality Assurance Officer - Aseptic Services

NHS AfC: Band 7

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

We are looking for an enthusiastic, self-motivated and responsible quality professional to develop their career in the evolving landscape of Quality Assurance and Aseptic Preparation, working closely with a variety of teams within Pharmacy.

Previous experience working in the quality assurance field is essential for this role and you will have ideally undertaken quality roles within aseptic services

The successful candidate will be working in the new St Thomas' Cancer & ATMP Aseptic Units and will be an integral member of the teams responsible for ensuring the successful validation and start up of these new facilities and its safe and effective operation.

Main duties of the job

- To support the QA team in the delivery of QA services, meeting the needs of the pharmacy department and all associated technical units. 

- To provide specialist quality advice to a range of technical and clinical areas within the Trust.

- To support the use of our pharmaceutical quality system tool and to assess SOPs, deviations, risk assessments, change controls and laboratory and microbiological out of specification results.

- To assist with internal auditing and inspection readiness activities.

Working for our organisation

Guy's and St Thomas' Pharmacy Technical Services is one of the largest NHS pharmacy technical departments in the country and employs over 120 staff across multiple manufacturing and preparation areas.  Our large on-site QA team provides support and guidance to all units providing technical services working under our MS, MIA(IMP) and WDA licences, as well as to units providing unlicensed 'Section 10' preparation services. This role is specific to the Section 10 preparation services within the Trust. 

Detailed job description and main responsibilities

Job Summary

The job holder will play a key role in quality assurance of the all medicines manufacturing and preparation activities ensuring a safe, efficient and compliant service.

Duties and Responsibilities

Quality Assurance

  1. To be part of the Quality Assurance (QA) team and carry out defined QA responsibilities as defined by the QA rotas.
  2. To support the QA team in the delivery of the QA service, meeting the needs of the pharmacy department according to legal requirements and licenses held by the Trust
  3. Provide support in the use of our quality management system tool, and assess and act on Deviations, Risk Assessments, CAPA, Change Controls and Temporary Changes. To monitor performance against agreed metrics and escalate non-compliance to senior managers.
  4. To critically assess deviations, risk assessments, change controls and CAPAs raised by production areas and provide QA sign off. To approve SOPs for use in production areas.
  5. Review out of specification physical and microbiological monitoring results and make decisions on suitability of the environment to be used and its impact on product quality.
  6. Support the unit teams to become Inspection Ready, particularly in the area of updating of key documents [e.g. SOPs, Specifications, Test Methods].
  7. As part of regulatory inspection readiness to ensure document availability and gather documented evidence to confirm resolution of deficiencies identified in our quality system.
  8. To assist QA Specialists with auditing activities.
  9. To lead on drug defect investigations and drug recalls within the Trust, including complaints.
  10. To investigate patient complaints of Trust manufactured products.
  11. To undertake validation reviews.
  12. To write departmental procedures in line with current guidelines.
  13. To carry out log meetings, quality review meetings and monthly trending meetings with production areas as required.
  14. To utilise the deviation reporting system and change control system and to trend the data.
  15. To be trained to use computerised facility monitoring systems and documentation systems. To act at all times in compliance with data integrity requirements.
  16. To act as a releasing officer for all medicinal products manufactured within the Trust and for NHS units with which the Trust has contracts.
  17. To provide QA support to procurement and governance teams in the assessment and approval of new unlicensed medicines to be bought into the Trust. To act as releasing officer for ULMs received into the Trust.
  18. To respond to queries appropriately.

Development

19. To investigate and implement the use of an electronic systems including archiving, quality management and manufacturing.

20. To undertake continuous professional development.

21. Assist the QA team in the development of the QA service.

22. To keep abreast of the latest QA guidelines, and ensure that all activities undertaken within the units meet current legislation such as GMP/GDP/GLP, COSHH etc.

Training

23. Assist in the training programme for QA personnel and other pharmacy personnel as required.

Other

24. To undertake other duties as required by the Deputy QA Manager and/or Head of Quality, including project work.

25. To deputise for QA Specialists where required to supervise QA support staff.

Please see attached Person Specification for further information.

Person specification

Knowledge/Qualifications

Essential criteria
  • Undergraduate or postgraduate Masters degree in a Science related discipline
  • Post graduate technical services qualification
  • Equivalent demonstrated portfolio of experience and short courses

Experience

Essential criteria
  • Previous QA experience in a pharmaceutical setting.
  • Experience of quality systems and document management systems.
  • Previous experience of the investigation, risk and impact assessment of deviations
  • Previous experience of GMP change management
Desirable criteria
  • Experience of aseptic preparation of CIVAS, Chemotherapy, TPN
  • Previous evaluated experience working as a releasing officer in a licenced pharmaceutical production unit with a comprehensive portfolio of products.
  • Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits.

Skills

Essential criteria
  • Demonstrated practical knowledge of GDP, GMP and QA.
  • Able to produce reports, spreadsheets and presentations using Microsoft packages.
  • Ability to direct and organise own time and time of others
  • Demonstrated ability to identify training needs of self and others
  • Ability to identify and solve problems
Desirable criteria
  • Demonstrated ability to identify and manage risks.
  • Ability to review and perform QA sign on documents written by others.
  • Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
  • Demonstrated ability to apply the principles of GCP and GMP to the running of clinical trials
  • Familiarity and demonstrated competence with use of computerised software systems for GMP activities and monitoring.

Employer certification / accreditation badges

Timewise helps businesses to attract and develop the best talent through flexible working.Care quality commission - GoodDisability confident employer

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

Apply online now

Further details / informal visits contact

Name
Saira Hussein
Job title
Aseptic Services Manager
Email address
[email protected]
Telephone number
02071885048
Apply online nowAlert me to similar vacancies