Job summary
The SPS National Quality Assurance Service 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 Deputy Regional Quality Assurance Pharmacist will work as part of a regional and national team in delivering successful patient outcomes by ensuring the choice of medicines in the NHS is evidenced based, safe, of high quality, value for money by working closely with the pharmaceutical Industry and NHS manufacturing units.
By working as part of an integrated SPS team, the post-holder will be able to facilitate making medicines optimisation routine practice across the NHS and will promote equal and equitable service provision.
The post holder will take a lead in the assessment of licensed pharmaceuticals on both regional and national procurement contracts and will deputise for the Regional Quality Assurance Pharmacist in their absence.
The job will involve a considerable amount of travelling, principally within the Midlands Region but also to other areas of England. The peripatetic role will include auditing, development of collaborative initiatives, training/CPD support and attendance at relevant meetings and networks.
To arrange an informal discussion with Lorna Purdy Director, Regional Quality Assurance please contact 07778 484264 lorna.purdy1@nhs.net
Main duties of the job
This peripatetic role will include: auditing, development of collaborative initiatives, training / CPD support and attendance at relevant meetings and network groups. To support NHS Organisations and Networks through the following:-
- To support the delivery of the national medicines optimisation agenda by providing specialist quality assurance advice at a national, regional and local level.
- Safeguarding patients through the quality assurance of medicines procured, prepared or manufactured by the NHS in the Midlands.
- To contribute 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.
- Development and implementation of best practice standards for manufacturing medicines in the NHS through audit, training, mentoring and advice.
- To support 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.
- To promote 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.
- Contribute to the development, implementation and delivery of the NHSE, SPS and NHS Pharmaceutical QA Committee work-plans.
About us
We are recognised as one of the leading NHS Foundation Trusts in the UK. Our vision is to Build Healthier Lives, and we recognise that we need incredible staff to do this.
Our commitment to our staff is to create the best place for them to work, and we are dedicated to:
Investing in the health and wellbeing of our staff, including a commitment of offering flexible working where we can;Offer our staff a wide variety of training and development opportunities, to support their personal and career development objectives.
UHB is committed to ensuring that our staff are treated fairly and feel that they belong, by creating a kind and inclusive environment. This is about equity of opportunity; removing all barriers, including discrimination and ensuring each individual member of staff reach their true potential, achieve their ambitions and thrive in their work. This is more than words. We are taking action. Our commitment to an inclusive culture is embedded at all levels of the organisation where every voice is heard, driven by our diverse and active staff networks, and at Board level by the Fairness Taskforce led by our CEO. We nurture a culture which empowers staff to challenge discriminatory behaviours and to enable people to bring their 'whole self' to a kinder, more connected and bold place to work.
Job description
Job responsibilities
*Please Note : For a detailed job description for this vacancy, please see attached Job Description*
Job description
Job responsibilities
*Please Note : For a detailed job description for this vacancy, please see attached Job Description*
Person Specification
Qualifications
Essential
- *Degree in Pharmacy
- *Registered with General Pharmaceutical Council (GPhC)
- *Post graduate Masters qualification in quality assurance practice or equivalent specialist experience
- *Postgraduate Masters in management or equivalent experience
Desirable
- *Registered as Qualified Person
- *MGPS(QC) as per HTM 2022
- *Member of the Royal Pharmaceutical Society
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
- *Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
- *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
Additional Criteria
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 understanding
- *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 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
- *Able to change into the appropriate clothing and spend time in pharmaceutical clean rooms and clinical areas
- *Able to travel to anywhere in the Midlands to start work on a site at 9:30am
- *Full UK driving licence / ability to travel between sites
Person Specification
Qualifications
Essential
- *Degree in Pharmacy
- *Registered with General Pharmaceutical Council (GPhC)
- *Post graduate Masters qualification in quality assurance practice or equivalent specialist experience
- *Postgraduate Masters in management or equivalent experience
Desirable
- *Registered as Qualified Person
- *MGPS(QC) as per HTM 2022
- *Member of the Royal Pharmaceutical Society
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
- *Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
- *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
Additional Criteria
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 understanding
- *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 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
- *Able to change into the appropriate clothing and spend time in pharmaceutical clean rooms and clinical areas
- *Able to travel to anywhere in the Midlands to start work on a site at 9:30am
- *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.
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).
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.
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).
