Job summary
We are looking to recruit an enthusiastic and motivated new member of staff to join our well- established Quality team within Technical Services.
The MHRA licenced 'Specials' pharmacy manufacturing unit is based at the Royal Stoke University Hospital and is a modern purpose-built unit within the hospital. The service encompasses the manufacture of sterile products, and the production of over labelling and re-packaging products, supplying both the trust and external organisations. The quality team are responsible for ensuring compliance with MHRA rules and guidelines and also supporting the manufacturing activities within the Pharmacy Technical services production team and the Radiopharmacy service at UHNM.
The role is required to support the further development of the service.
Main duties of the job
Assist 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.
Assist in ensuring compliance with the terms of the Medicines and Healthcare Products Regulatory Authority (MHRA) Manufacturer's 'Specials' Licence, ICH and other national guidelines related to pharmaceutical manufacturing and reconstitution or repackaging activities.
Support PQMS including electronic and paper-based documentation systems ensuring compliance to the requirements of MHRA GxP data Integrity
Support the routine environmental monitoring of cleanroom facilities.
Support the future development of the Pharmacy Services delivered to patients across the organisation. This is in line with the Directorate Business Plan and the Trust Vision and Strategic Objectives
Monitor Key Performance Indicators and support the development of performance dashboards for pharmacy technical services
Participate in appropriate rotas, including weekend and bank holiday working
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
To achieve this, for the band 5 role you will need to have - extensive and recent experience of Pharmaceutical Quality Management systems, for example change control, deviation investigations, and CAPA management. The band 4 role may be offered to applicants with little or no experience with robust objectives being set to be achieved to progress to Band 5 level (Target within 2 years). Applicants should also be able to demonstrate excellent organisational, communication and digital skills and a high degree of attention to detail and the ability to work on their own or as part of a team.
Job description
Job responsibilities
To achieve this, for the band 5 role you will need to have - extensive and recent experience of Pharmaceutical Quality Management systems, for example change control, deviation investigations, and CAPA management. The band 4 role may be offered to applicants with little or no experience with robust objectives being set to be achieved to progress to Band 5 level (Target within 2 years). Applicants should also be able to demonstrate excellent organisational, communication and digital skills and a high degree of attention to detail and the ability to work on their own or as part of a team.
Person Specification
Essential Qualifications
Essential
- Band 4/5-NVQ3 in Pharmaceutical Sciences OR Level 3 Science Manufacturing Technician (SMT) in Pharmaceutical Science OR An undergraduate degree in the chemical, biological or sciences
- Band 4/5-Registered, or eligible to be registered, with the GPhC, Science Council (SMT), Royal Society of Chemistry, Royal Society of Biology
Desirable
- Registered Quality Controller (MGPS)
- Relevant additional training in GMP / Pharmacy Technical Services
Knowledge, Skills, Training and Experience
Essential
- Extensive and recent experience of Pharmaceutical quality systems. For example change control, deviation investigations, and CAPA management.
- Knowledge of cleanroom design and functioning
- Computer literate, high standard of Oral and written communication skills
- Ability to work to standard operating procedures
- Methodical with effective organisational skills able to meet deadlines and manage time effectively
Desirable
- Experience of cleanroom environmental monitoring methods
- Ability to work to standard operating procedures
- Ability to influence staff in the resolution of difficult or ambiguous problems
Person Specification
Essential Qualifications
Essential
- Band 4/5-NVQ3 in Pharmaceutical Sciences OR Level 3 Science Manufacturing Technician (SMT) in Pharmaceutical Science OR An undergraduate degree in the chemical, biological or sciences
- Band 4/5-Registered, or eligible to be registered, with the GPhC, Science Council (SMT), Royal Society of Chemistry, Royal Society of Biology
Desirable
- Registered Quality Controller (MGPS)
- Relevant additional training in GMP / Pharmacy Technical Services
Knowledge, Skills, Training and Experience
Essential
- Extensive and recent experience of Pharmaceutical quality systems. For example change control, deviation investigations, and CAPA management.
- Knowledge of cleanroom design and functioning
- Computer literate, high standard of Oral and written communication skills
- Ability to work to standard operating procedures
- Methodical with effective organisational skills able to meet deadlines and manage time effectively
Desirable
- Experience of cleanroom environmental monitoring methods
- Ability to work to standard operating procedures
- Ability to influence staff in the resolution of difficult or ambiguous problems
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)
