Job summary

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.

As the Regional Quality Assurance Lead Pharmacist you will lead and manage the regional QA team to deliver the QA service to the region.

This will involve supporting the delivery of the national medicines optimisation agenda by providing specialist leadership and quality assurance advice at a national, regional and local level.

Main duties of the job

Providing quality assurance advice to improve the safety of all medicines preparation, manufacture and distribution (licensed and unlicensed activity) in NHS organisations

Developing, contributing to, implementing and mentoring compliance of quality standards for the safe use of medicines

Providing highly complex specialist QA advice and support to NHS organisations and networks on a range of specialist topics

Developing best practice guidance and resources

Aseptic Preparation Audits

Leadership to the technical service workforce

Procurement Support to National and Regional Contracting of Medicines

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

Providing oversight of medical gas systems in NHS organisations

Research and innovation, service development

Regional Quality Assurance Team - Professional Leadership and management

About us

North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.

North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.

Job description

Job responsibilities

The post holder will lead and manage the regional QA team to deliver the QA service to the region.

This will involve supporting the delivery of the national medicines optimisation agenda by providing specialist leadership and quality assurance advice at a national, regional and local level. This will include:

• Contributing to the patient safety agenda through the provision of quality assurance expertise and support to the procurement, preparation and manufacture of medicines and medicines provider services 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
• Supporting 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 supporting the development, implementation and safe use of new medicines (e.g. ATMP, clinical trials, 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 acute NHS Trusts in the region. To support the regions Chief Pharmacist network and Reginal 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

Job description
Job responsibilities

The post holder will lead and manage the regional QA team to deliver the QA service to the region.

This will involve supporting the delivery of the national medicines optimisation agenda by providing specialist leadership and quality assurance advice at a national, regional and local level. This will include:

• Contributing to the patient safety agenda through the provision of quality assurance expertise and support to the procurement, preparation and manufacture of medicines and medicines provider services 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
• Supporting 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 supporting the development, implementation and safe use of new medicines (e.g. ATMP, clinical trials, 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 acute NHS Trusts in the region. To support the regions Chief Pharmacist network and Reginal 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

Person Specification

Education/Training/Qualification

Essential

• Degree in Pharmacy
• Registered with the General Pharmaceutical Council
• Further qualification (Post Graduate Diploma/MSC) within Pharmaceutical Technology or QA.

Desirable

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

Work 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 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 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

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/Skills/Abilities

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 the regulatory and NHS standards and guidance relating to medicines procurement and supply 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 n relation to manufacture, preparation and supply of medicines, including clinical trials
• Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or when dealing with uncertainty to inform professional judgement
• Excellent presentation and facilitation skills within small groups, large workshops and virtual audiences
• Self-motivated with excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities. Ability to work effectively on own and as part of a multi-disciplinary team
• 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 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 ability to accurately produce documentation and presentations using Microsoft packages

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

Personal Qualities/Special Circumstances

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 Region

Desirable

• Facility for remote/home working

Person Specification
Education/Training/Qualification

Essential

• Degree in Pharmacy
• Registered with the General Pharmaceutical Council
• Further qualification (Post Graduate Diploma/MSC) within Pharmaceutical Technology or QA.

Desirable

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

Work 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 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 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

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/Skills/Abilities

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 the regulatory and NHS standards and guidance relating to medicines procurement and supply 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 n relation to manufacture, preparation and supply of medicines, including clinical trials
• Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or when dealing with uncertainty to inform professional judgement
• Excellent presentation and facilitation skills within small groups, large workshops and virtual audiences
• Self-motivated with excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities. Ability to work effectively on own and as part of a multi-disciplinary team
• 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 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 ability to accurately produce documentation and presentations using Microsoft packages

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

Personal Qualities/Special Circumstances

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 Region

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 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 .

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. .
UK Registration

Applicants must have current UK professional registration. For further information please see

Additional information
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 .

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. .
UK Registration

Applicants must have current UK professional registration. For further information please see

Employer details

Employer name

North Bristol NHS Trust
Address

Southmead Hospital

Southmead Road

Bristol

BS10 5NB

Employer's website