Quality Assurance Specialist

4 weeks ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

Pharmaceutical Quality Assurance Specialist

We are looking for excellent quality professionals to join our Quality Team based predominantly at the Guys site. Ideally you will have experience working in the pharmaceutical industry or NHS in quality assurance.

The post provides 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 dosage forms under the MS and MIA(IMP) licences, in addition to unlicensed (Section 10) preparation.
- To lead and deliver Pharmaceutical QA Services to the Trust Pharmacy Manufacturing, Section 10 Preparation and Quality Control Units.
- To be responsible for maintaining the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the ML(Specials), MA(IMP) licences and NHS guidance.
- To act as a Releasing Officer for products manufactured under the MS(Specials) and MA(IMP) licences.
- To provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.

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.

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.

Service management
- To ensure that the pharmaceutical quality management system is maintained and developed in accordance with the ML(Specials) 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 act as a Releasing Officer for products manufactured under the ML(Specials) and MA(IMP) licences.
- 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 complain 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.

Personnel Management, Training and Development
- 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 monito

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