About this role
Job summary
We're delighted to offer a fantastic opportunity to join our close-knit Quality Assurance team at the Bristol Royal Infirmary, where you'll take a leading role in our Quality Control laboratory and serve as a Releasing Officer for sterile and non-sterile medicinal products, manufactured under our MHRA 'specials' licence.
You'll be supported by a small, dedicated team of Quality Assurance Technical Officers, working collaboratively to uphold the highest standards of pharmaceutical quality and patient safety.
This role is ideal for someone looking todevelop a career in Quality Assurance, with hands-on experience in product release and laboratory oversight. We are deeply committed to staff development and will provide:
Comprehensive in-house training Funded external training opportunitiestailored to your personal development goals If you're passionate about quality, thrive in a collaborative environment, and want to make a meaningful impact in healthcare, we'd love to hear from you.
Main duties of the job
1. To participate in the day to day operation and organisation of the QC Laboratory in accordance with current Good Manufacturing Practice (EU GMP) and the documented quality system.
2. To be a QC Releasing Officer for raw materials, containers, prepacked and over labelled products, non-sterile and aseptic medicinal products manufactured under the Manufacturer's "Specials" (MS) Licence (issued by the MHRA, Medicines and Healthcare products Regulatory Agency).
3. To participate in the provision of pharmacy technical services in accordance with Good Manufacturing Practice (EU GMP) and the documented quality system.
4. To communicate effectively within the QC and across technical services departments to ensure a robust quality assurance approach is applied to the manufacture and development of medicinal products.
5. To contribute to the Pharmaceutical Quality Management System including attendance at quality review meetings when required.
6. To develop own skills and knowledge and contribute to the training and development of others.
About us
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a combined workforce of over 13,000 staff and over 100 different clinical services across 10 different sites, serving a core population of more than 500,000 people across South West England. UHBW has been rated by the CQC as 'Good' overall and our staff are proud to deliver excellent care to the people of Bristol, Weston and beyond. As a forward- thinking multi-award winning Trust and a digital exemplar committed to improving patient care, our world-leading research and innovations are having a positive local and global impact. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone's throw of the countryside or beside the seaside, both with easy access to all that the South West has to offer. UHBW is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them. Anonymous information will be used from your application in order to ensure we're meeting our pledge.
Job description Job responsibilities
Please refer to the Job Description & Person Specification for full details of the job role and responsibilities.
Person Specification
Qualifications and Training Essential
Relevant science degree or equivalent Member of a professional bodies (Royal Society of Biology, Royal Society of Chemistry or the Royal Pharmaceutical Society/General Pharmaceutical Council) or eligibility to register as a member Relevant postgraduate qualification (e.g. PTQA, STP) or willingness to complete appropriate formal training for subsequent qualification
Desirable
COSHH and/or Risk Assessor
Knowledge and Experience Essential
Minimum two years post-qualification relevant GMP experience In depth knowledge of QC Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and related legislation Experience of working with a Pharmaceutical Quality Management System Substantial experience of aseptic preparation
Desirable
Good knowledge of the responsibilities of releasing medicinal products Experience of working in a laboratory undertaking analysis Ability to assess and manage risk in relation to manufacture and testing of medicinal products Basic knowledge of microbiology
Skills and Abilities Essential
Good analytical skills and working with accuracy/precision Good IT skills including data analysis through the application of databases Ability to plan and prioritise workload on daily and monthly basis Risk assessment skills
Aptitudes Essential
Exceptional communication, time management and prioritisation skills Ability to act independently and always consider the safety implications of product release over request for product Excellent attention to detail
Desirable
Able to complete routine and repetitive tasks within defined guidelines and processes
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.
Certificate of Sponsorship 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).
Employer details Employer name Bristol NHS Foundation Trust
Address Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Employer's website https://www.uhbw.nhs.uk/ (Opens in a new tab)