Deputy Regional Quality Assurance Specialist

Job 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 the North West Chief Pharmacists and networks.

To monitor compliance against standards/implement against audit/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.

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 North West 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 EL audit programme. These audits are undertaken at a frequency of no less than once every 18 months. Identifying and assessing patient safety risks and highlighting deficiencies through audit, oversight and monitoring of corrective actions, informing senior management and escalation to NHSE where appropriate.

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 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 NHSE Assurance of Aseptic Preparation of Medicines Guidance with 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.

Duties include:

Undertake audits of unlicensed NHS medicines manufacturing facilities that aseptically prepared sterile medicines for patients as required NHSEs Assurance of Aseptic Preparation of Medicines Guidance. (March 2023)

Provide promptly, a full audit report in writing via the IQAAPs system, to the Chief Pharmacist responsible for each such aseptic preparation unit and provide summary audit reports similarly to the Trust Chief Executive and when required escalate to NHSE via the pathways documented in the NHSE Guidance.

Provide audit reports that give a clear risk assessment of the service provided and provide details of any required remedial action (within given timescales) to improve aspects of the service with regard to patient safety. Should such an audit inspection uncover critical failings or lapses in good manufacturing practice that constitute (in the opinion of the post holder) a critical risk to patient safety, the post holder has the authority to seek the immediate closure of the facility until such time as satisfactory remedial action can be taken. The post holder has the authority to seek such a closure by escalation pathways involving recourse to the Trust Chief Pharmacist, Trust Chief Executive and NHSE as necessary.

Attend MHRA Inspectorate audits of licensed NHS manufacturers and liaise with the MHRA and the unit concerned, with regard to any safety or quality issues identified.

Undertake audits of commercial manufacturers of licensed and unlicensed medicines and medical devices, wishing to supply to the NHS or in response to product defect complaints with existing suppliers.

Undertake audits of third parties providing service to the NHS, which have a direct impact on patient care (e.g. contract analytical laboratories, homecare companies).

Undertake audits of other aspects of hospital pharmacy services on request such as extemporaneous dispensing of medicines, use and procurement of unlicensed medicines and good laboratory practice in Quality Control laboratories.

Undertake the development of new and existing pharmaceutical audit tools for local, regional and national use.

Use and contribute to various audit databases applicable to this work.

MRHA Drug and Device Alerts

To liaise with the Defective Medicines Report Centre of the MRHA where problems have been reported and SPS advice is required to notify the system with and without the instigation of a national drug/device recall.

To facilitate upwards reporting to NHS England of serious or potentially serious or significant medicines- related incidents or errors arising in pharmacy services and to ensure that relevant information and learning points from these and relevant incidents elsewhere in the trust or NHS are widely and promptly disseminated and that lesson are learned appropriate action taken to minimise the risk of recurrence.

To support the Regional QA Specialists in disseminating information and actions required in response to Drug Alerts and Recalls..

Networking and Committees

To support and encourage networking and good practice by participating in regional and national networks as appropriate.

To participate in and support as necessary, the activities of the NHS QA Committee Procurement Sub- Group meetings.

To represent the Regional Quality Assurance Pharmacists as required on Regional and national committees (such as the NHS QA Committee) as necessary.

Providing oversight of medical gas systems in NHS Organisations

Input to standard setting for best practice and input to the NHS Health Technical Memorandum or equivalent, aligned to the SPS Medical Gas Committee.

Provide advice to support the commissioning and re-qualification of medical gas systems.

Provide expert advice and support for Chief Pharmacists with regard to their duties in delivering the medical gas agenda.

Freedom to Act

The post holder will be responsible for managing their own workload, working alone and be solely responsible and accountable for decisions made. The job will involve a considerable amount of travelling, principally within the North West but also to other areas within England.

Other Duties

To undertake other reasonable duties as requested by the Regional Quality Assurance Pharmacists, SPS QA Hub Lead or the Director of SPS.

To undertake any other duties that may be required appropriate to the postholders grade, experience and competence.

Participate in personal individual performance review and continuing education programmes in order to maintain knowledge and improve standards of service.

Attend all mandatory and Trust required training on a periodical basis as specified by the relevant Legislation / policy.

To, at all times, practice in accordance with the Code of Ethics of the Royal Pharmaceutical Society of Great Britain, whether registered with the RSPGB or not.

To take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the Incident, Serious Incidents and Near Misses reporting policy and procedure.

Qualifications

Essential

• Degree in Pharmacy
• Registered with General Pharmaceutical Council (GPhC)
• Post graduate Masters qualification in quality assurance practice or equivalent specialist experience

Desirable

• Registered as Qualified Person
• MGPS(QC) as per HTM 2022
• Member of the Royal Pharmaceutical Society
• Postgraduate Masters in management

Knowledge & Experience

Essential

• Significant experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
• Significant experience of quality control testing of pharmaceuticals (chemistry and microbiology methods)
• Significant experience of risk management and quality management systems and their application
• Significant experience of auditing and self inspection and report writing to meet pharmaceutical regulatory requirements
• Significant experience of planning and delivery of training (large and small groups) to more junior and also peer groups
• Significant experience of multi-disciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
• Significant experience and evidence of successful development and implementation of policies and procedures to satisfy regulatory requirements
• Significant experience of formulation, preparation and the assignment of appropriate shelf lives for prepared medicines
• Significant experience of working with regulatory authorities
• Significant experience of working in both regional and national networks
• Led on projects and or demonstrated an ability to direct their own work
• Current understanding of the NHS and the role of pharmacy within it
• Highly developed specialist knowledge of the regulatory and NHS standards and guidance relating to medicines manufacture and preparation
• Highly developed specialist knowledge of the regulatory and NHS standards anmd guidance relating to safe storage and supply of medicines
• Highly developed knowledge of the regulatory and NHS standards and guidance relating to medicines procurement and supply
• Specialist knowledge of the standards and guidance relating to homecare medicines services
• Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
• Specialist knowledge of clean room design, technology and operation for pharmaceutical processing
• Thorough understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
• Good understanding of pharmacy law in relation to manufacture, preparation and supply of medicines
• Understanding of health and safety legislation as applicable to medicines manufacture and preparation

Desirable

• Experience in all areas of hospital pharmacy services including dispensary, clinical services and storage and distribution
• Experience of quality control testing of medical gases from both cylinders and pipeline systems
• Experience of procurement of medicines and product assessment
• Understanding of medical gases, their distribution and use in hospitals

Skills and Ability

Essential

• Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or there are barriers to
• Excellent presentation and facilitation skills within both small groups and large workshops
• Excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities
• Excellent investigational and analytical skills with an ability to provide advice in highly complex situations
• Excellent interpersonal skills. Diplomatic, consultative and able to build consensus to successfully gain agreement and commitment with peers and customers Able to cope with conflict and handle difficult situations with a calm disposition
• Demonstrates leadership management negotiation and motivational skills to facilitate working within and leading a team of staff
• Demonstrates tact, empathy and diplomacy when communicating confidential sensitive or contentious information
• Ability to coach and mentor others
• Ability to work effectively on own and as part of a multi-disciplinary team
• Able to concentrate for prolonged periods while dealing with interruptions
• Able to show empathy to colleagues under pressure
• Able to communicate clearly good and poor audit finding and actions necessary to more senior trust staff
• Able to challenge data or views expressed by colleagues
• Good internet skills to include searches and website management
• Good IT skills ability to accurately produce documentation and presentations using Microsoft packages

Other specific requirements

Essential

• Able to change into the appropriate clothing and spend time in pharmaceutical clean rooms and clinical areas
• Able to travel to anywhere in the North West to start work on a site at 9:30am
• Ability to motivate and influence the work of others
• Full UK driving licence / ability to travel between sites

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).