Do you want to work in one of the best performing NHS organisations in England? Work for an organisation that was voted the best acute and combined acute and community trust in the country, based on the experience of its staff (NHS Staff Survey 2022). Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn’t, this is what you get when you work for Northumbria Healthcare and, this is…the Northumbria Way!
What the Northumbria Way means for you :
* Extensive staff health and well-being programme including access to our specialist Wellbeing Hub
* Support and connection through a variety of Staff Network groups
* A range of flexible working opportunities
* Generous annual leave and pension scheme
* Access to lease car and home electronics scheme (qualifying criteria applies)
* Opportunities to improve your professional development through our vast training programmes
* On-site nursery places via salary sacrifice
* Access to savings scheme via salary sacrifice with Northumberland Community Bank
We are proud to be one of the country’s top performing NHS trusts – rated ‘outstanding’ overall by the Care Quality Commission (CQC). We provide a range of health and care services to support more than 500,000 people living in Northumberland and North Tyneside across the largest geographical area of any NHS Trust in England. Our teams deliver care from hospitals, a range of community venues and people’s homes. Our hospitals include a specialist emergency care hospital (the first of its kind in England), three general hospitals and community hospitals. In the community we deliver a wide range of community and public health services.
We lead in innovation and quality, having opened the Northumbria Healthcare Manufacturing and Innovation Hub during the Covid-19 pandemic and have recently launched our Community Promise – a pledge to make a real impact not just in healthcare but on the wider factors that affect people’s lives, such as education, employment and the economy.
If Northumbria Healthcare sounds like somewhere you could belong we would love to hear from you. Visit our website to catch up on our latest news.
Job overview
An exciting opportunity has arisen for a highly organised and proactive Quality Assurance Officer to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland.
The MMC is in its final design stages, with facility construction planned through to September 2025. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations.
This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care.
Main duties of the job
* To contribute to the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
* Support QA activities for products and processes under the MMC’s MS Licence, ensuring the compliance with MHRA and NHS standards.
* Provides technical QA resource, advice, and support to ensure GMP compliance at the MMC.
* Responsible for managing and training Quality Assurance staff.
* Manages the team that assures the quality of and release unlicensed medicines to the value of approximately £20 million per annum.
Working for our organisation
We manage three major locality hospitals at North Tyneside, Wansbeck and Hexham, plus a number of smaller community hospitals and clinics from Tynemouth to Berwick on Tweed, in addition to our state-of-the-art Northumbria Specialist Emergency Care Hospital, the first of its kind in England. We also care for people in their homes and provide services from facilities in local communities such as health centres. We give people greater choice and control over their care to help them to live independently at home and avoid hospital admission where appropriate. High quality patient care is at the heart of everything we do and we strive to ensure every single patient and service user has an exceptional experience with us. We have one of the most extensive patient experience programmes of any trust in England.
Detailed job description and main responsibilities
* To support and maintain the Pharmaceutical Quality System (PQS) within the Medicines Manufacturing Centre (MMC), ensuring compliance with Good Manufacturing Practice (GMP), NHS guidance, and MHRA regulations.
* To complete relevant aspects of the PQS reporting systems e.g. Documentation Control, revision and approval, Change Control, Deviations, Quality Risk Assessments, Root Cause Analysis, Micro non-conformances, Complaints, Supplier Approval, Key Performance Indicator Trending, Quality Technical Agreements and Training Processes.
* To co-ordinate and perform the review, approval, and monitoring of QA processes, documentation, and release of products, as well as ensuring continuous improvement and regulatory compliance.
* To participate on investigations involving the quality of pharmaceutical products across the MMC
* To manage the Quality Assurance staff during day-to-day operations and longer-term planning
* To plan and implement a strategy to ensure a robust and fit for purpose Quality Assurance workforce throughout the product lifecycle
* To develop and monitor quality KPIs which demonstrate the state of control of the facility, and report these to the senior management team
* To role model compassionate and inclusive leadership to shape the creation of a collective leadership culture within the Trust.
Person specification
Qualifications / Professional Registration
* Degree in Pharmacy, Chemistry, Biology, or a related scientific field or equivalent experience.
* Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level with a Postgraduate Diploma in Pharmaceutical Technology or similar.
* Eligible to be registered with the General Pharmaceutical Council (GPhC), Health and Care Professions Council (HCPC), Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB) or Royal Pharmaceutical Society (RPS).
* Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or be willing to work towards a Diploma / Master’s degree while in post.
* Professional Registration
Experience and knowledge
* Knowledge of GMP and MHRA guidelines and experience of working in a regulated environment.
* Extensive experience in the management and maintenance of pharmaceutical quality systems.
* Evidence of continuing education/professional CPD
* Evidence of managing product release.
* Evidence of successfully managing a team
* Experience in manufacture of sterile medicines
* Experience of training colleagues in GMP
* Knowledge of or experience in coaching and mentoring practices and tools
* Knowledge of or experience in Quality improvement tools, techniques and methods.
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