Job summary
Senior Regional Pharmacy Quality Assurance Specialist - London and South East Regions-Specialist PharmacyService(SPS)
Grade 8b 1 year fixed term contract
Based at Guy's Hospital in London. 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.
Applicants should have significant experience encompassing hospital pharmaceutical production, preparation, quality assurance, 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:
David Cope - Regional Deputy Director Pharmaceutical Quality Assurance on 07884 311066 david.cope@nhs.net or
Nadia Rolf - Regional Director Pharmaceutical Quality Assurance on 07592 399841 n.rolf@nhs.net
Main duties of the job
KEY RESPONSIBILITIES
Developing, contributing to, implementing and mentoring compliance of quality standards for the safe use of medicines
- To work and liaise with regulators and expert advisory groups (MHRA, BP, EAHP, RPS, GPhC).
- To develop and implement national and regional quality assurance standards.
- Support local and regional service development and innovation, showcasing best practice.
- To respond to relevant UK and EU medicines consultations on behalf of London and South East Chief Pharmacists and networks.
- To monitor and audit compliance with existing and developing standards.
- Supporting others in developing standards.
- To represent Regional Chief Pharmacists and Regional Quality Assurance Service, at the National Pharmaceutical Quality Assurance Committee as necessary
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 Specialists are responsible to the Quality Assurance function of SPS.
The Senior Regional Quality Assurance Specialist 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.
By working as part of an integrated SPS team, the Senior Regional Quality Assurance Specialist will be able to facilitate making medicines optimisation routine practice across the NHS and will promote equal and equitable service provision for all NHS patients.
The post holder will take a lead in the assessment of licensed pharmaceuticals on both regional and national procurement contracts.
Job description
Job responsibilities
Providing quality assurance advice to improve the safety of all medicines preparation, manufacture and distribution (licensed and unlicensed activity) in NHS organisations.
Provide expert advice to London and South East NHS organisations carrying out sterile and non-sterile traditional batch manufacture, aseptic preparation, radiopharmacy, extemporaneous preparation, repackaging & over-labelling, wholesaler dealing, clinical trials and quality control laboratory services.
Supporting the effective implementation and embedding of best practice quality standards through audit, training and mentoring.
Provide regulatory oversight to NHS unlicensed aseptic preparation through delivery of the Assurance of Aseptic Preparation Audit Programme. Identifying and assessing patient safety risks and highlighting deficiencies through audit. Application of the iQAAPs digital, GMP-based audit and compliance management system to manage a number of activities including; reporting, oversight, monitoring of corrective actions and quality indicators. Informing senior management and escalation to NHSE. The audit frequency is risk based but the maximum interval between audits is no more than two years.
Supporting NHS organisations in obtaining and retaining MHRA licences.
To provide quality input to the design and validation of clean rooms, facilities and equipment for manufacturing medicines.
Provision of expertise in formulation, R&D, sterility assurance and pharmaceutical microbiology to support safe preparation, dispensing and administration of medicines.
Improving patient outcomes through the provision of pharmacovigilance advice in relation to medicine quality e.g. following adverse incidents/drug recalls.
Supporting investigations and reviews, when requested, into patient incidents, where medicines have caused harm by providing expert technical advice and assistance.
Supporting Trusts in meeting regulatory requirements with regard to safe and secure storage and handling of medicines e.g. CQC, Home Office, GPhC, MHRA.
To provide expert opinion and advice relating to national guidance and regulatory aspects of medicines management to customers. This includes Good Distribution Practice (GDP), safe and secure handling of medicines-controlled drugs, temperature-controlled storage, COSHH issues, Disposal of waste.
The post holder will undertake audits, carry out risk assessments and help to develop audit tools relating to unlicensed and licensed manufacturing/preparative services units in the Region. The post holder will attend audit inspections by the Medicines and Healthcare Products Regulatory Agency (MHRA) of licensed NHS manufacturing units, on request and liaise between the MHRA and the unit concerned, with regard to any safety or quality issues identified. The post holder will undertake audit inspections of unlicensed NHS aseptic preparation units as directed under the NHSE Assurance of Aseptic Preparation Audit Programme with regard to compliance with good manufacturing practice. The post holder is required to undertake audits of medicines manufacturing and preparation facilities of suppliers of medicines and medical devices to the NHS. Audits are undertaken to assess compliance of manufacturers with standards of good manufacturing practice.
Job description
Job responsibilities
Providing quality assurance advice to improve the safety of all medicines preparation, manufacture and distribution (licensed and unlicensed activity) in NHS organisations.
Provide expert advice to London and South East NHS organisations carrying out sterile and non-sterile traditional batch manufacture, aseptic preparation, radiopharmacy, extemporaneous preparation, repackaging & over-labelling, wholesaler dealing, clinical trials and quality control laboratory services.
Supporting the effective implementation and embedding of best practice quality standards through audit, training and mentoring.
Provide regulatory oversight to NHS unlicensed aseptic preparation through delivery of the Assurance of Aseptic Preparation Audit Programme. Identifying and assessing patient safety risks and highlighting deficiencies through audit. Application of the iQAAPs digital, GMP-based audit and compliance management system to manage a number of activities including; reporting, oversight, monitoring of corrective actions and quality indicators. Informing senior management and escalation to NHSE. The audit frequency is risk based but the maximum interval between audits is no more than two years.
Supporting NHS organisations in obtaining and retaining MHRA licences.
To provide quality input to the design and validation of clean rooms, facilities and equipment for manufacturing medicines.
Provision of expertise in formulation, R&D, sterility assurance and pharmaceutical microbiology to support safe preparation, dispensing and administration of medicines.
Improving patient outcomes through the provision of pharmacovigilance advice in relation to medicine quality e.g. following adverse incidents/drug recalls.
Supporting investigations and reviews, when requested, into patient incidents, where medicines have caused harm by providing expert technical advice and assistance.
Supporting Trusts in meeting regulatory requirements with regard to safe and secure storage and handling of medicines e.g. CQC, Home Office, GPhC, MHRA.
To provide expert opinion and advice relating to national guidance and regulatory aspects of medicines management to customers. This includes Good Distribution Practice (GDP), safe and secure handling of medicines-controlled drugs, temperature-controlled storage, COSHH issues, Disposal of waste.
The post holder will undertake audits, carry out risk assessments and help to develop audit tools relating to unlicensed and licensed manufacturing/preparative services units in the Region. The post holder will attend audit inspections by the Medicines and Healthcare Products Regulatory Agency (MHRA) of licensed NHS manufacturing units, on request and liaise between the MHRA and the unit concerned, with regard to any safety or quality issues identified. The post holder will undertake audit inspections of unlicensed NHS aseptic preparation units as directed under the NHSE Assurance of Aseptic Preparation Audit Programme with regard to compliance with good manufacturing practice. The post holder is required to undertake audits of medicines manufacturing and preparation facilities of suppliers of medicines and medical devices to the NHS. Audits are undertaken to assess compliance of manufacturers with standards of good manufacturing practice.
Person Specification
Knowledge/Qualifications
Essential
- Pharmacist, Scientist, Pharmacy Technician
- Registered with the General Pharmaceutical Council or member of the Royal Society of Chemistry, Institute of Biology or other equivalent body
Previous experience
Essential
- Wide and varied experience in NHS hospital pharmaceutical production, quality assurance and quality control
- Audit work and report writing
Desirable
- Has worked in and managed a licensed or unlicensed pharmacy aseptic unit
- Experience in industrial pharmaceutical production, quality assurance and quality control
Skills
Essential
- Current understanding of the NHS and the role of pharmacy within it
- Demonstrated practical knowledge of GMP, GDP, GCP etc. and all current regulations. Demonstrated expert technical knowledge of pharmaceutical QA and GMP and a proven ability to apply this knowledge to develop and maintain quality systems
- Able to communicate clearly good and poor audit finding and actions necessary to more senior Trust staff.
Person Specification
Knowledge/Qualifications
Essential
- Pharmacist, Scientist, Pharmacy Technician
- Registered with the General Pharmaceutical Council or member of the Royal Society of Chemistry, Institute of Biology or other equivalent body
Previous experience
Essential
- Wide and varied experience in NHS hospital pharmaceutical production, quality assurance and quality control
- Audit work and report writing
Desirable
- Has worked in and managed a licensed or unlicensed pharmacy aseptic unit
- Experience in industrial pharmaceutical production, quality assurance and quality control
Skills
Essential
- Current understanding of the NHS and the role of pharmacy within it
- Demonstrated practical knowledge of GMP, GDP, GCP etc. and all current regulations. Demonstrated expert technical knowledge of pharmaceutical QA and GMP and a proven ability to apply this knowledge to develop and maintain quality systems
- Able to communicate clearly good and poor audit finding and actions necessary to more senior Trust staff.
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).
