Job summary
University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.
Please see below for the detailed job description of the role.
Main duties of the job
An exciting opportunity has arisen for enthusiastic, highly motivated, detail focussed individuals to join our friendly Quality Assurance team performing essential tasks that support our aseptic manufacturing units. The roles will cover a range QA activities including managing the Pharmacy Quality System, validation, audits and environmental microbiological oversight.
This is an exciting opportunity to be part of small Quality Assurance team of highly professional and dedicated staff, with an opportunity to integrate with our larger sterile production teams, with the overall aim to provide an excellent, quality driven service.
About us
University Hospital Southampton is one of England's largest acute teaching Trusts, offering a wide range of learning and development opportunities to support your career aspirations.
Located on the south coast with an international airport and direct rail links to London, Southampton offers an ideal setting to live and work, with the New Forest, South Downs and Jurassic Coast.
We believe that using technology wisely shows strong time management and commitment to innovation. However, personalizing your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI-generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.
At UHS we're committed to providing a flexible working environment where possible. Whether you are balancing family, study, or your wellbeing with your career, we want to support you so you can help our patients.
At UHS, we proudly champion individuality, recognizing that outstanding care is only possible with a diverse, inclusive team. We're committed to creating an anti-racist, anti-discriminatory environment where everyone feels valued, safe, and empowered to make a meaningful impact in our communities. We welcome applicants of all backgrounds, identities, and experiences to join us in building a healthcare community where everyone can belong, thrive, and contribute.
Job description
Job responsibilities
The successful applicant will lead and manage the Pharmaceutical Quality Management System (QMS), ensuring compliance with all relevant licensing and regulatory standards, including MHRA Specials manufacture and Section 10 working.
You will be responsible for the day-to-day management of the QMS, including change control, deviations and CAPAs, out-of-specification/out-of-trend investigations, internal and external audits, risk assessments, customer and supplier complaints, recalls, and documentation control.
As a Senior Quality Assurance Officer, you should be able to demonstrate proficiency in one or more key QA areas, such as overall QMS management, validation, auditing, or environmental microbiology oversight.
A keen eye for detail, demonstrable regulatory knowledge and experience, and excellent written and verbal communication skills are essential for this role. When combined with a passion for continuous quality improvement and a proactive approach to managing your own work, these qualities will make you ideally suited to this position.
Job description
Job responsibilities
The successful applicant will lead and manage the Pharmaceutical Quality Management System (QMS), ensuring compliance with all relevant licensing and regulatory standards, including MHRA Specials manufacture and Section 10 working.
You will be responsible for the day-to-day management of the QMS, including change control, deviations and CAPAs, out-of-specification/out-of-trend investigations, internal and external audits, risk assessments, customer and supplier complaints, recalls, and documentation control.
As a Senior Quality Assurance Officer, you should be able to demonstrate proficiency in one or more key QA areas, such as overall QMS management, validation, auditing, or environmental microbiology oversight.
A keen eye for detail, demonstrable regulatory knowledge and experience, and excellent written and verbal communication skills are essential for this role. When combined with a passion for continuous quality improvement and a proactive approach to managing your own work, these qualities will make you ideally suited to this position.
Person Specification
Trust Values
Essential
- Patient First
- Always Improving
- Working Together
Qualifications, knowledge and experience
Essential
- Master's degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or equivalent level of experience of GMP Quality Assurance / Quality Control)
- Experience in Good Manufacturing Practice (GMP) in relation to the production of sterile medicines
- Experience of dealing with complex pharmaceutical issues which requires analysing information from a range of sources
- Detailed knowledge of Quality Assurance and Quality Management Systems including relevant experience of audits, validation requirements, investigations, including microbiological, deviations and complaints and change management
- Experience of implementing and working with an electronic quality management system (eQMS)
- Experience of developing and implementing Standard Operating Procedures (SOPs) and policies
- Experience in audits, validation, and quality preparation of guidelines & procedures and writing of reports
Desirable
- Postgraduate certificate or diploma in relevant field or further education in Pharmacy Technical Services e.g. PTQA
- Experience in preparing and presenting at meetings
Person Specification
Trust Values
Essential
- Patient First
- Always Improving
- Working Together
Qualifications, knowledge and experience
Essential
- Master's degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or equivalent level of experience of GMP Quality Assurance / Quality Control)
- Experience in Good Manufacturing Practice (GMP) in relation to the production of sterile medicines
- Experience of dealing with complex pharmaceutical issues which requires analysing information from a range of sources
- Detailed knowledge of Quality Assurance and Quality Management Systems including relevant experience of audits, validation requirements, investigations, including microbiological, deviations and complaints and change management
- Experience of implementing and working with an electronic quality management system (eQMS)
- Experience of developing and implementing Standard Operating Procedures (SOPs) and policies
- Experience in audits, validation, and quality preparation of guidelines & procedures and writing of reports
Desirable
- Postgraduate certificate or diploma in relevant field or further education in Pharmacy Technical Services e.g. PTQA
- Experience in preparing and presenting at meetings
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).
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).
