Southwest Regional Quality Assurance Lead Pharmacist
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
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
- Degree in Pharmacy
- Registered with the General Pharmaceutical Council
- Further qualification (Post Graduate Diploma/MSC) within Pharmaceutical Technology or QA.
- Medical Gas testing (Quality Controller MPGS)
- Qualification in management
Work Experience
- 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
- 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
- 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
- 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
- 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
- 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.
£94,356 to £108,814 a yearper annum, pro rata for part time roles
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