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Quality Assurance Specialist

4 months ago

Liverpool, United Kingdom Liverpool University Hospitals NHS Foundation Trust Full time

This is a high profile and complex role, requiring advanced communication and presentation skills.

We are part of the Specialist Pharmacy Service which includes Regional Pharmaceutical Quality Assurance, Procurement, and Medicines Information providing a service to NHS hospitals across the North West.

The Pharmacy Practice Unit is hosted by the Royal Liverpool and Broadgreen University Hospitals NHS Trust. There are opportunities for home working. Periodic travel to base site in Liverpool and North West Hospital sites is required.

Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University Hospital NHS Foundation Trust and the Royal Liverpool and Broadgreen University Hospitals NHS Trust.

The merger provides an opportunity to reconfigure services in a way that provides the best healthcare services to the city and improves the quality of care and health outcomes that patients experience.

The Trust runs Aintree University Hospital, Broadgreen Hospital, Liverpool University Dental Hospital and the Royal Liverpool University Hospital.

It serves a core population of around 630,000 people across Merseyside as well as providing a range of highly specialist services to a catchment area of more than two million people in the North West region and beyond.

To deliver a range of specialist Quality Assurance duties as part of the NW Quality assurance team including:
Medicine Preparation Audit & Support

To ensure the safety of patients by the monitoring and assessment of medicine preparation (sterile, non-sterile and aseptic) in the North West NHS Trusts through:

- Audit of unlicensed aseptic units in accordance with EL 97(52).
- Supporting Trusts in the design and validation and operation of clean rooms, facilities and equipment.
- Providing specialist advice to technical service managers with regard to sterility assurance, pharmaceutical microbiology, cleanroom technology, medicines formulation, stability and process validation

Quality Risk Management of the Medicines Supply chain

To provide a highly specialist service to underpin the procurement of licensed and unlicensed medicines to NHS Trusts within the North West Region to optimise the quality, safety and efficacy of medicines and related products used by all NHS Hospitals in the North West.
- Supporting licensed and unlicensed medicines contracting through:

- development of service/tender specifications and technical agreements.
- assessment of suppliers through audit and evaluation of quality risk management systems to ensure compliance with service specifications and regulatory requirements.
- Assessing the pharmaceutical quality of medicines and medical devices and their potential for medication error.
- Evaluation of scientific and technical reports relating to medicines e.g. drug stability reports.
- Providing on-going contract support by reviewing quality indicators and liaising closely with suppliers to resolve quality issues.
- Facilitating the effective communication of drug alerts and recalls from the MHRA to Trusts.
- Reviewing and assessing reports of defective medicines from Trusts, liaising with suppliers where required and submitting summaries to the national reporting system.

Safe and secure handling & distribution of medicines
- 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.

Workforce development

To support the Regional QA Pharmacist in providing leadership and development of the technical service workforce in the North West.
- To develop and deliver education and training for all aspects of Quality Assurance. This will include the development of e-learning packages and the delivery of lectures and workshops, as required across the North West Region.
- To provide support to the technical service workforce across the North West. This will include on-site support and mentoring as necessary.
- Supporting National SPS work streams in the development of best practice guidance.
- Supporting NW networks in the implementation of best practice guidance.
- Maintenance of a NW Quality Assurance website to make national and local guidance readily available.

Quality System Management
- To support the development, implementation and review of quality systems within the PPU. This will include the procurement, QA and QC teams.
- Supporting the NW QC laboratories in maintaining their MHRA & UKAS accreditation, including provision of specialist advice during inspections.
- To provide activity reports relating to key performance indicator (KPI) delivery for the QA