Job summary
Deputy Regional Pharmacy Quality Assurance Specialist - London and South East Regions-Specialist PharmacyService(SPS)
This role is part of the national team in delivering successful patient outcomes by ensuring the choice of medicines in the NHS is evidenced-based, safe, high quality, value for money and readily available. Medicines safety is assured by incorporating effective systems of quality risk management into the procurement, manufacturing, preparation and administration of medicines.
The role incorporates audit of NHS unlicensed aseptic facilities as well as sites that hold a manufacturers 'specials' licence.
In addition, support to the Commercial Medicines Unit and procurement teams including assessment of medicinal products for suitability for purchasing contracts and provision of training and education to all levels of pharmacy staff.
Applicants should have significant experience encompassing hospital pharmaceutical production, preparation, quality assurance, quality control, inspection and audit and have a sound knowledge of GMP, GDP, GCP and pharmacy legislation.
Thereis a requirement to travel frequently throughout London and the South East regions.
For further information and an informal discussion please contact:
Nadia Rolf - Director Pharmaceutical Quality Assurance on 07592 399841
Main duties of the job
The 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, preparedor manufactured by the NHS in London and South East.- To contribute to the patient safety agenda through the provision of quality assurance expertise and support to the procurement, preparation and manufacture of medicinesand medicines provider services to the NHS.- Development and implementation of best practice standards for manufacturingmedicines 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
The Specialist Pharmacy Service (SPS) National Quality Assurance (QA) 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 Regional Quality Assurance Pharmacists are responsible to the Quality Assurance function of the SPS.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, and readily available by working closely with the pharmaceutical Industry and NHS manufacturing units. Medicines use will be made as safe as possible by incorporating effective systems of quality risk management into their procurement, manufacturing, preparation and administration.
Job description
Job responsibilities
Please review the attached Job Description for further information regarding the main responsibilities of this role
Job description
Job responsibilities
Please review the attached Job Description for further information regarding the main responsibilities of this role
Person Specification
Knowledge/Qualifications
Essential
- Degree in Pharmacy or equivalent level qualification in a related discipline with relevant experience in a pharmaceutical field
- 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 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
- Demonstrates leadership management negotiation and motivational skills to facilitate working within and leading a team of staff
Experience
Essential
- Significant experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
- Significant experience of auditing and self inspection and report writing to meet pharmaceutical regulatory requirements
- Significant experience of multi-disciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
- Highly developed knowledge of the regulatory and NHS standards and guidance relating to medicines procurement and supply
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
Skills
Essential
- Excellent presentation and facilitation skills within both small groups and large workshops
- 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
- Able to concentrate for prolonged periods while dealing with interruptions
- Able to communicate clearly good and poor audit findings and actions necessary to more senior trust staff
- Good IT skills ability to accurately produce documentation and presentations using Microsoft packages
Person Specification
Knowledge/Qualifications
Essential
- Degree in Pharmacy or equivalent level qualification in a related discipline with relevant experience in a pharmaceutical field
- 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 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
- Demonstrates leadership management negotiation and motivational skills to facilitate working within and leading a team of staff
Experience
Essential
- Significant experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
- Significant experience of auditing and self inspection and report writing to meet pharmaceutical regulatory requirements
- Significant experience of multi-disciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
- Highly developed knowledge of the regulatory and NHS standards and guidance relating to medicines procurement and supply
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
Skills
Essential
- Excellent presentation and facilitation skills within both small groups and large workshops
- 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
- Able to concentrate for prolonged periods while dealing with interruptions
- Able to communicate clearly good and poor audit findings and actions necessary to more senior trust staff
- Good IT skills ability to accurately produce documentation and presentations using Microsoft packages
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).
