Quality Assurance Specialist

Job content

Following the Government announcement and subsequent legislative requirement, health care workers must be fully vaccinated against COVID 19 as a condition of deployment before April 22. Successful applicants must have had their first Covid-19 vaccination by 3rd February 2022. Conditional offers of employment will include the need for the candidate to evidence their COVID 19 vaccination status or medical exemption letter as part of their pre-employment checks. Covid passes and medical exemptions can be applied for via https://www.nhs.uk/conditions/coronavirus-covid-19/covid-pass/

The successful candidate will either be educated to masters level in pharmacy, pharmaceutical sciences, chemistry, Medicines Management and Pharmacy services or, have a post graduate qualification in Pharmaceutical Technology and Quality Assurance. You will also have extensive experience in GMP, NHS standards relating to the manufacture, preparation, storage and supply of medicines.

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.

As a Quality Assurance Specialist the successful candidate will deliver, as part of the team but leading on certain activities, a range of specialist quality assurance duties including medicines preparation audit and support, quality risk management of the medicines supply chain, safe and secure handling and distribution of medicines, workforce development and quality system management.

The North West Regional Pharmaceutical Quality Assurance team are seeking to recruit a highly motivated, enthusiastic and forward thinking individual to join our small, friendly team based at the Pharmacy Practice Unit in Liverpool.

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.
• Supporting Trusts in applying for and maintaining their MHRA Specials licences, including provision of specialist advice during MHRA inspections.
• 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.
• Supporting Trusts in in applying for and maintaining their MHRA WDA licences, including provision of specialist advice during MHRA inspections.

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 Service.
• To review relevant national guidance and current regulatory requirements to ensure local and regional guidance is compliant.
• To propose changes for own specialist area which may impact on other disciplines

Other Duties

• To undertake any other duties that may be required appropriate to the postholder’s grade, experience and competence.
• To be aware of personal responsibilities under Health & Safety regulations.

To co-operate with risk assessments and ensure that risks are identified and reported as they arise