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Technical Services Quality Systems Specialist | Guy's and St Thomas' NHS Foundation Trust

Posting date:	24 July 2024
Salary:	Not specified
Additional salary information:	£58,698 - £65,095 p.a. inclusive of HCA
Hours:	Full time
Closing date:	04 September 2024
Location:	London, SE1 9RT
Company:	Guys and St Thomas NHS Foundation Trust
Job type:	Permanent
Job reference:	6497934/196-LIS8730

Summary

Technical Services Quality Systems Specialist

We are looking for an excellent and motivated quality professional to join our technical services teams at Guys and St Thomas'. Ideally you will have experience working in the pharmaceutical industry or NHS manufacturing units in a production supervision or quality oversight roles.

This is a new post that will lead on the completion of quality documentation within the production units. Your focus will be on responding to deviations and other non conformance and ensuring impact and risk assessments, root cause analysis and actions plans are developed and implemented. You will also be involved in change management, undertaking and responding to audits and supporting the implementation of new products and trials

The post provides an excellent opportunity for healthcare scientists or a Pharmacist to utilise and develop your GMP and quality systems knowledge, skills and experience and prepare you for progression within Production or Quality Assurance in the future with the opportunity to work alongside experienced quality professionals.

· To lead and deliver on the writing and review of unit quality system documents and ensure these are completed within required time frames.

· To ensure deviations are impact and risk assessed and investigated within the agreed timelines and escalated as appropriate.

· To oversee responses to audit findings and ensure these are responded to within agreed timelines.

· To support the management review of the quality system and monitor and action agreed metrics.

· Provide training and development on quality related matters to unit staff
• Where appropriate, and within regulatory frameworks, to act as a Releasing Officer for unlicensed medicines and products manufactured under the MS(Specials) and MA(IMP) licenses and aseptically prepared products under the section 10 exemption

· To provide technical support and advice to other departments in the Trust and to external customers of the Trust

· To oversee the unit’s validation master plan and re-qualification plan and ensure this is kept up to date and the required validation actions for new and existing systems are completed

· To implement new products including clinical trials following internal procedures, regulatory and legal requirements and product information.

· To review errors reports, investigate error trends, develop action plans and feedback to staff key learning

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, 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.

Service management

1) To ensure that the pharmaceutical quality management system is maintained and developed in accordance with the ML(Specials), MA(IMP) licence and Quality Assurance of Aseptic Preparation Services requirements as required and in response to changes in regulations and legislation.

2) To provide senior quality input into writing and reviewing all quality documentation, focusing input into complex issues, to ensure satisfactory completion within agreed time frames.

3) To review target closure dates and ensure completion on time or risk assessed extention of due dates.

4) To undertake a regular senior review of all deviations according to department procedures.

5) 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.

6) Where appropriate, and within regulatory frameworks, to act as a Releasing Officer for unlicensed medicines and products manufactured under the MS(Specials) and MA(IMP) licenses and aseptically prepared products under the section 10 exemption.

7) To carry out Trust GMP Internal Audits and Patrol Audits and that these audits are reported and actioned in a timely manner.

8) To review and update all QA documentation as required in accordance with GMP.

9) To maintain and develop the documentation control system in accordance with GMP.

10)To be responsible for ensuring that all the requirements for the validation master plan and requalification plans are fully completed and documented and the validation master plan is kept up to date with changes and new equipment and systems.

11)In collaboration with other senior unit staff, to oversee the recording, analysis, trending, preventative actions and reporting back to staff of internal errors.

12)To review and coordinate the service contracts and technical agreements with suppliers.

13)To respond to customer complaints and undertake drug defect investigation for Trust manufactured products.

14)To report drug defects on purchased products to manufacturer’s and communicate response to end user.

15)To support the Trust response to Drug Alerts issued by the MHRA.

Personnel Management, Training and Development

1) To supervise the work of the Technical services quality system officers and all staff working on the quality system, 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.

2) To ensure that all staff working on quality systems documents are trained and competency assessed in the tasks they undertake and through staff development involve all unit staff in completion of quality system activities.

3) To be responsible for the recruitment and selection process for staff alongside unit accountable pharmacists and production managers.

Service evaluation and development

1) To critical assess the current quality management systems with a view to maintaining a continuous quality improvement cycle within the department.

2) To be responsible for updating and enhancing current unit documentation in line with accepted guidelines and changes in the workings of the department. To ensure changes are documented and controlled following department procedures.

3) To attend regulatory and internal audits and meet the requirements of the auditor in a clear and concise manner. To take ownership for agreed aspects of the response to audit deficiencies and ensure agreed action plans are completed in a timely manner.

4) To be responsible for the planning and introduction of new documents to manage and monitor developments within the department.

5) To undertake risk assessment activities within the Trust to identify high risk activities that could be managed within the resources of the department.

6) To assist in other practice research and in service development in accordance with jointly agreed objectives between the post holder and Accountable Pharmacist / Production Manager.

Clinical trials

1) To review new trials from a quality and operational perspective to ensure that the protocol, authorisation and ethical approval meets the requirements of The Medicines for Human Use (Clinical Trial) Regulations 2004.

2) To review new trial documentation and assess whether the production of the Investigational Medicinal Product (IMP) comes under the MA (IMP) licence. To ensure that all IMP production (licensed and unlicensed) follows the principles of GMP and GCP and follows the departments quality management system.

3) To author and review IMP change controls, actions forms and production documentation to ensure the preparation of the IMP complies with all regulatory requirements.

4) 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.

5) To lead in the response to audit deficiencies in a timely manner as required.

Research and Development


1) To provide quality 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 Development Scientist.


2) To provide quality input to ensure the key objectives within the validation master plan for pharmacy manufacturing are met.


3) 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.

Clinical services

1) To provide expert pharmaceutical advice on the use of all other products prepared by manufacturing and preparation units.

2) To undertake documented risk assessments to determine the most appropriate location for injectable medicine preparation.

3) To assess the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate.

4) To respond to MHRA Drug Alerts and coordinate the retrieval, quarantine and replacement of stock.

5) To support on the documentation and communication of Drug Alerts to all relevant areas of the Trust.



This advert closes on Thursday 22 Aug 2024