Dewislen

Senior Regional Pharmacy Quality Assurance Specialist London SE SPS

Manylion swydd
Dyddiad hysbysebu: 13 Mawrth 2026
Cyflog: Heb ei nodi
Gwybodaeth ychwanegol am y cyflog: £64,455 - £74,896 pa
Oriau: Llawn Amser
Dyddiad cau: 12 Ebrill 2026
Lleoliad: London, SE1 9RT
Cwmni: Guys and St Thomas NHS Foundation Trust
Math o swydd: Cytundeb
Cyfeirnod swydd: 7857362/196-LIS10354M

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Crynodeb

A Vacancy at Guy's and St Thomas' NHS Foundation Trust.


Senior Regional Pharmacy Quality Assurance Specialist- London and South East Regions- Specialist Pharmacy Service (SPS)

Grade 8b 1 year fixed term contract

Based at Guy’s Hospital in London. This role is part of the national team in delivering successful patient outcomes by ensuring the choice of medicines in the NHS is evidenced-based, safe, high quality, value for money and readily available. Medicines safety is assured by incorporating effective systems of quality risk management into the procurement, manufacturing, preparation and administration of medicines.


Applicants should have significant experience encompassing hospital pharmaceutical production, preparation, quality assurance, inspection and audit and have a sound knowledge of GMP, GDP, GCP and pharmacy legislation.There is a requirement to travel frequently throughout London and the South East regions.



For further information and an informal discussion please contact:

David Cope – Regional DeputyDirector Pharmaceutical Quality Assurance on 07884 311066 david.cope@nhs.netor

Nadia Rolf – RegionalDirector Pharmaceutical Quality Assurance on07592 399841n.rolf@nhs.net



KEY RESPONSIBILITIES



Developing, contributing to, implementing and mentoring compliance of quality standards for the safe use of medicines


• To work and liaise with regulators and expert advisory groups (MHRA, BP, EAHP, RPS, GPhC).
• To develop and implement national and regional quality assurance standards.
• Support local and regional service development and innovation, showcasing best practice.
• To respond to relevant UK and EU medicines consultations on behalf of London and South East Chief Pharmacists and networks.
• To monitor and audit compliance with existing and developing standards.
• Supporting others in developing standards.
• To represent Regional Chief Pharmacists and Regional Quality Assurance Service, at the National Pharmaceutical Quality Assurance Committee as necessary





The Specialist Pharmacy Service (SPS) National Quality Assurance (QA) Service supports the principles of medicines optimisation by the development and championing of best practice and by ensuring continuous improvement through the implementation of quality risk management systems in NHS medicines manufacturing & preparation and NHS supply chain management. The Regional Quality Assurance Specialists are responsible to the Quality Assurance function of SPS.



The Senior Regional Quality Assurance Specialist will work as part of a regional and national team in delivering successful patient outcomes by ensuring the choice of medicines in the NHS is evidenced based, safe, of high quality, value for money, and readily available by working closely with the pharmaceutical Industry and NHS manufacturing units. Medicines use will be made as safe as possible by incorporating effective systems of quality risk management into their procurement, manufacturing, preparation and administration.

By working as part of an integrated SPS team, the Senior Regional Quality Assurance Specialist will be able to facilitate making medicines optimisation routine practice across the NHS and will promote equal and equitable service provision for all NHS patients.

The post holder will take a lead in the assessment of licensedpharmaceuticals on both regional and national procurement contracts.



Providing quality assurance advice to improve the safety of all medicines preparation, manufacture and distribution (licensed and unlicensed activity) in NHS organisations.

· Provide expert advice to London and South East NHS organisations carrying out sterile and non-sterile traditional batch manufacture, aseptic preparation, radiopharmacy, extemporaneous preparation, repackaging & over-labelling, wholesaler dealing, clinical trials and quality control laboratory services.

· Supporting the effective implementation and embedding of best practice quality standards through audit, training and mentoring.

· Provide regulatory oversight to NHS unlicensed aseptic preparation through delivery of the Assurance of Aseptic Preparation Audit Programme. Identifying and assessing patient safety risks and highlighting deficiencies through audit. Application of the iQAAPs digital, GMP-based audit and compliance management system to manage a number of activities including; reporting, oversight, monitoring of corrective actions and quality indicators. Informing senior management and escalation to NHSE. The audit frequency is risk based but the maximum interval between audits is no more than two years.

· Supporting NHS organisations in obtaining and retaining MHRA licences.

· To provide quality input to the design and validation of clean rooms, facilities and equipment for manufacturing medicines.

· Provision of expertise in formulation, R&D, sterility assurance and pharmaceutical microbiology to support safe preparation, dispensing and administration of medicines.

· Improving patient outcomes through the provision of pharmacovigilance advice in relation to medicine quality e.g. following adverse incidents/drug recalls.

· Supporting investigations and reviews, when requested, into patient incidents, where medicines have caused harm by providing expert technical advice and assistance.

· Supporting Trusts in meeting regulatory requirements with regard to safe and secure storage and handling of medicines e.g. CQC, Home Office, GPhC, MHRA.

· To provide expert opinion and advice relating to national guidance and regulatory aspects of medicines management to customers. This includes Good Distribution Practice (GDP), safe and secure handling of medicines-controlled drugs, temperature-controlled storage, COSHH issues, Disposal of waste.



The post holder will undertake audits, carry out risk assessments and help to develop audit tools relating to unlicensed and licensed manufacturing/preparative services units in the Region. The post holder will attend audit inspections by the Medicines and Healthcare Products Regulatory Agency (MHRA) of licensed NHS manufacturing units, on request and liaise between the MHRA and the unit concerned, with regard to any safety or quality issues identified. The post holder will undertake audit inspections of unlicensed NHS aseptic preparation units as directed under the NHSEAssurance of Aseptic Preparation Audit Programmewith regard to compliance with good manufacturing practice. The post holder is required to undertake audits of medicines manufacturing and preparation facilities of suppliers of medicines and medical devices to the NHS. Audits are undertaken to assess compliance of manufacturers with standards of good manufacturing practice.






This advert closes on Tuesday 31 Mar 2026

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