Job summary
Pharmacy Quality Manager - Technical Services- Band 8a
Full time - equating to 37.5 hours per week
We are seeking an experienced and highly motivated individual to join our well established Pharmacy Technical Services team and lead the Quality Service.
The Quality Team support the MHRA licenced 'Specials' pharmacy manufacturing unit based at the Royal Stoke University Hospital in a modern purpose built facility. The service encompasses aseptic, chemotherapy and pre-pack operations (over labelling and repackaging products) supplying both the Trust and external organisations. The quality team also support the quality systems of the wider pharmacy team as well as the licensed activities within the Radiopharmacy service at UHNM.
As a department we continually strive to re-engineer and improve our services to enhance the delivery of patient focused pharmaceutical care and customer satisfaction.
Main duties of the job
Act as the named Person Responsible for Quality Control under the terms of the MHRA Manufacturer's 'Specials' Licence across both Pharmacy and Imaging Departments and be the named site contact
Lead on ensuring compliance with the terms of the Medicines and Healthcare Products Regulatory Authority (MHRA) Manufacturer's 'Specials' Licence, ICH and other national guidelines and standards related to pharmaceutical manufacturing and reconstitution or repackaging activities
Lead in the operation of, maintenance of and development of the Pharmacy Quality Management Systems (PQMS) meeting the changing requirements of the department, the Trust and external regulators
Act as the Quality Controller in regard of the preparation of Radiopharmaceuticals within the Department of Nuclear Medicine
To achieve this, you will need excellent organisational, communication and digital skills with a strong attention to detail. You will need to be able to work effectively within a team.
You will be supported by an experienced team and encouraged to undertake further training and education to enhance your personal development.
This is an exciting time to be a part of the Pharmacy Technical Services Team at UHNM.
About us
University Hospitals of North Midlands NHS Trust is one of the largest and most modern in the country. Based across two sites, Royal Stoke in Stoke-on-Trent and County Hospital in Stafford, we are proud to serve around three million people and we're highly regarded for our facilities, teaching and research. We are the specialist centre for major trauma for the North Midlands and North Wales.
All of our employees make a valuable contribution regardless of role here at UHNM and we are proud of our wide range of development packages aimed at ensuring that everyone has the opportunity to fulfil their true potential.
UHNM create and encourage a culture of inclusion, providing equal opportunities for career development that are fair and transparent. We are committed to being a diverse and inclusive employer and foster a culture in which all staff feel valued and respected. In return we ask all of our employees to make a commitment to the values, co-created by or staff, patients and carers, and that unite us as a Trust.
At University Hospitals of North Midlands NHS Trust we know that investing in, supporting and developing our staff has a direct impact on the quality of care that we deliver. Our employees are as important as our patients and the population that we serve.
Job description
Job responsibilities
Detailed job description and main responsibilities
For more information on this vacancy, please see the attached Job Description and Person Specification or contact the Hiring Manager Nicky Stringer
Nicky Stringer,Deputy Clinical Director of Pharmacy
01782 674508 nicky.stringer@uhnm.nhs.uk
Job description
Job responsibilities
Detailed job description and main responsibilities
For more information on this vacancy, please see the attached Job Description and Person Specification or contact the Hiring Manager Nicky Stringer
Nicky Stringer,Deputy Clinical Director of Pharmacy
01782 674508 nicky.stringer@uhnm.nhs.uk
Person Specification
Essential Qualifications
Essential
- Undergraduate degree in Pharmacy, Chemistry or Biological Sciences, minimum 2:1
- Registered, or eligible to be registered, with the GPhC, Science Council (SMT), Royal Society of Chemistry or Royal Society of Biology
- OR NVQ3 in Pharmaceutical Sciences
- OR Level 3 Science Manufacturing Technician (SMT) in Pharmaceutical Science
Desirable
- Relevant further education / additional learning GCP and ICH certification
- Leadership and/or management qualification
- STP Qualification
- PTQA qualification
Knowledge, Skills, Training and Experience
Essential
- Substantial experience in a Quality role within Aseptic Services in an MHRA licensed facility
- Experience in preparing and providing support during external audit and accreditation
- Ability to develop and implement new and updated procedures Knowledge of cleanroom environmental monitoring methods and ability to review and analyse trend data.
- Able to work on own initiative including planning and organising the work of the team
- Knowledge of commissioning qualification and validation of equipment / digital systems.
Person Specification
Essential Qualifications
Essential
- Undergraduate degree in Pharmacy, Chemistry or Biological Sciences, minimum 2:1
- Registered, or eligible to be registered, with the GPhC, Science Council (SMT), Royal Society of Chemistry or Royal Society of Biology
- OR NVQ3 in Pharmaceutical Sciences
- OR Level 3 Science Manufacturing Technician (SMT) in Pharmaceutical Science
Desirable
- Relevant further education / additional learning GCP and ICH certification
- Leadership and/or management qualification
- STP Qualification
- PTQA qualification
Knowledge, Skills, Training and Experience
Essential
- Substantial experience in a Quality role within Aseptic Services in an MHRA licensed facility
- Experience in preparing and providing support during external audit and accreditation
- Ability to develop and implement new and updated procedures Knowledge of cleanroom environmental monitoring methods and ability to review and analyse trend data.
- Able to work on own initiative including planning and organising the work of the team
- Knowledge of commissioning qualification and validation of equipment / digital systems.
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).
Employer details
Employer name
University Hospital of North Midlands NHS Trust
Address
Royal Stoke University Hospital
Newcastle Road
Stoke on Trent
ST4 6QG
Employer's website
https://www.uhnm.nhs.uk (Opens in a new tab)
