Regional Quality Assurance Pharmacist (East of England)

NHS; United Kingdom; Remote; GBP 45,000 - 60,000; Full time

Job summary

A healthcare organization is looking for a leader to manage the QA team in the East of England. The successful candidate will provide quality assurance expertise, manage compliance, and develop best practice resources for NHS medicines. This role requires a degree in Pharmacy and extensive experience in QA and pharmaceutical management.

Qualifications

• Extensive post-registration experience in Good Manufacturing Practice.
• Significant experience in quality control testing of pharmaceuticals.
• Experience in planning and delivering training to groups.

Responsibilities

• Providing complex QA advice to NHS organizations.
• Leading development of articles for the SPS website.
• Developing webinars and podcasts to promote best practice.

Skills

Excellent communication skills

Excellent presentation and facilitation skills

Self-motivated with excellent time management

Excellent investigational and analytical skills

Excellent interpersonal skills

Demonstrates leadership and management skills

Ability to coach and mentor others

Good IT skills

Education

Degree in Pharmacy

Registered with General Pharmaceutical Council

Further qualification (MSC) in Pharmaceutical Technology or QA

Job description

Job Summary

The post holder will lead and manage the regional QA team to deliver the QA service to the East of England region. This includes:

• Provision of quality assurance expertise and support to the procurement, preparation and manufacture of medicines and medicines provider service to the NHS.
• Leading the programme of audit of NHS aseptic units across the region and provide support and oversight of high risk units through a programme of compliance management.
• Developing web‑based best practice resources for the quality assurance of medicines in the NHS and support implementation through audit, training, mentoring and advice.
• Taking a lead across organisations in the development and implementation of quality risk management systems to underpin the principles of medicines optimisation and ensure consistently effective outcomes for patients.
• Promoting innovation and transformation in the NHS by taking a lead in development, implementation, and safe use of new medicines (e.g. clinical trials, ATMP, biological medicines) and technologies through working with regulators, academia and industry.
• Formulating, directing and delivering strategic plans for the provision of QA services to the NHS Trusts in the region. To support the region's Chief Pharmacist network and Regional Chief Pharmacist in delivering agreed work plans.
• Contributing to the development, implementation and delivery of the NHSE, SPS and NHS Pharmaceutical QA Committee work plans.

Main Duties of the Job

The Specialist Pharmacy Service (SPS) National Quality Assurance (QA) Service is an expert advisory service that supports the principles of medicines optimisation by the development and championing of best practice and by ensuring continuous improvement through the implementation of quality risk management systems in NHS medicines manufacturing & preparation and NHS supply chain management.

The SPS QA Function provides specialist advice relating to the quality of medicines to NHS pharmacy professionals to support safe patient care. The scope of our advisory and consultancy service includes:

• Aseptic preparation of medicines
• Manufacturing of unlicensed medicines
• Assigning shelf life to medicines
• Temperature controlled storage and distribution of medicines
• Assessing the pharmaceutical quality of medicines

The types of advisory and resources we provide include:

• Responses to queries and requests for help
• SPS articles
• Multi‑media resources
• Exemplar procedures and templates
• Risk management materials for assessment of medicines
• Injectable medicines stability tool
• Audit reports
• Focused support to regional projects and NHS Trusts
• Participation in regional and national pharmacy networks and staff development events.

Job Responsibilities

• Providing highly complex specialist QA advice and support to NHS organisations and networks on a range of specialist topics.
• Leading and contributing to the development of articles for the SPS website relating to the quality assurance of medicines.
• Developing and participating in webinars and podcasts to educate and promote best practice.
• Liaising with regulators and expert advisory groups (MHRA, BP, CHM, EAHP, RPS, GPhC) in the development and implementation of quality assurance standards for medicines.
• Supporting local and regional service development and innovation, showcasing best practice.
• Responding to relevant UK and EU medicines consultations on behalf of SPS, Regional Chief Pharmacists and regional networks.

Person Specification

Qualifications (Essential)

• Degree in Pharmacy
• Registered with General Pharmaceutical Council
• Further qualification (MSC) within Pharmaceutical Technology or QA

Qualifications (Desirable)

• Medical Gas testing (Quality Controller MPGS)
• Qualification in management

Experience (Essential)

• Extensive post‑registration 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 junior and peer groups.
• Significant experience of multidisciplinary working and evidence of successful management of significant changes in complex environments.
• Significant experience of developing and implementing policies and procedures to satisfy regulatory requirements.
• Significant experience of working in both regional and national networks.
• Significant experience of working with regulatory authorities.
• Experience in all areas of NHS hospital pharmacy services including dispensary, clinical services and storage & distribution.

Experience (Desirable)

• Experience of working in radiopharmacy services.
• Experience of working with clinical trials.
• Experience of quality control testing of medical gases.
• Experience of procurement of medicines and product assessment.

Knowledge (Essential)

• 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 and guidance relating to safe storage and supply of medicines.
• Highly developed knowledge of medicines procurement and supply guidance including homecare services.
• Highly developed knowledge of pharmaceutics, medicine formulation and drug stability.
• Good general and current knowledge of NHS developments and strategies relevant to medicines quality including primary and secondary care.
• Specialist knowledge of clean‑room design, technology and operation for pharmaceutical processing.
• Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation.
• Thorough understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation.
• Comprehensive understanding of pharmacy law and regulations relating to manufacture, preparation and supply of medicines, including clinical trials.

Knowledge (Desirable)

• Good knowledge of ATMPs.
• Awareness of national pharmaceutical contracting strategies including outsourced medicine compounding and homecare services.
• Understanding of health and safety legislation as applicable to medicines manufacture and preparation.

Skills (Essential)

• Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including complex or uncertain information.
• Excellent presentation and facilitation skills within small groups, large workshops and virtual audiences.
• Self‑motivated with excellent time management and organisational skills, capable of planning and scheduling complex activities and working effectively alone and as part of a multidisciplinary team.
• Excellent investigational and analytical skills with the ability to provide advice in highly complex situations.
• Excellent interpersonal skills: diplomatic, consultative and able to build consensus to gain agreement and commitment; capable of coping with conflict and handling difficult situations calmly.
• Demonstrates tact, empathy and diplomacy when communicating confidential, sensitive or contentious information.
• Demonstrates leadership, management, negotiation, influencing and motivational skills to facilitate working across healthcare systems.
• Ability to coach and mentor others.
• Good IT skills and ability to produce accurate documentation and presentations using Microsoft packages.

Other Essential

• Able to change into appropriate clothing and spend time in pharmaceutical clean rooms and clinical areas.
• Able to travel anywhere in the East of England.

Other Desirable

• Facility for remote/home working.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and will require a Disclosure and Barring Service 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 https://www.gov.uk/visa-and-immigration-visa-faqs.

UK Registration

Applicants must have current UK professional registration. For further information please see https://www.nhs.uk/careers.

Employer Details

Employer: Liverpool University Hospitals NHS Foundation Trust

Address: Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF

Website: https://www.liverpoolft.nhs.uk/