Job summary
- Main area
- Medicines Manufacturing Centre
- Grade
- NHS AfC: Band 7
- Contract
- Permanent
- Hours
- Full time
- Flexible working
- Compressed hours
- Job ref
- 319-7385837JN
- Employer
- Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust
- Employer type
- NHS
- Site
- Manufacturing and Innovation Hub
- Town
- Seaton Delaval
- Salary
- £47,810 - £54,710 per annum
- Salary period
- Yearly
- Closing
- 03/09/2025 23:59
Employer heading
QA Validation Specialist
NHS AfC: Band 7
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.
Whilst Northumbria Healthcare are a highly innovative organisation, the use of Third Party Artificial Intelligence (AI) presents a risk to the integrity of our Recruitment & Selection processes. If you use AI, and it poses a risk to the integrity your individual recruitment process, we may withdraw your application at any stage of the process.
Job overview
An exciting opportunity has arisen for a proactive and passionate QA Validation Specialist 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. 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. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.
All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved
Main duties of the job
What You’ll Be Doing
You will be responsible for maintaining validation systems and quality assurance processes, ensuring compliance with EU GMP and regulatory requirements.
Key Responsibilities:
- Develop and manage the Validation Master Plan (VMP) and oversee new equipment introduction, validation, and revalidation.
- Lead Quality Risk Management (QRM) activities for process design, ensuring Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) are effectively managed.
- Provide QA oversight of Process Validations, including Aseptic Process Simulation (APS), operator validation, gowning validation, and cleaning validation.
- Manage outsourced activity, including supplier approval, Quality Technical Agreements, and contractor oversight.
- Oversee the Contamination Control Strategy (CCS) and environmental monitoring program in collaboration with the Site Microbiologist.
- Support QA capacity planning and oversee unit crisis management procedures and site shutdown planning.
- Deliver QA system training across MMC to ensure compliance and staff competency.
- Promote continuous improvement and innovation to enhance quality, compliance, and operational efficiency.
Working for our organisation
The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. This cutting-edge centre is part of the North East and North Cumbria Provider Collaborative and has been established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products.
Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, particularly for oncology and other high-risk therapies, while creating skilled jobs and driving innovation across the region. The facility is designed to operate under a Manufacturer’s Specials Licence (MS) and aims to secure a Wholesale Dealer’s Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.
At the MMC, quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to building a culture of openness, learning, and continuous improvement—offering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.
Working at the MMC means being part of a forward-thinking and supportive team focused on enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.
Detailed job description and main responsibilities
To support and maintain all validation activities within the MMC to ensure they are all carried out in compliance with EU GMP.
To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to equipment management i.e. Validation Master Plan (VMP), New equipment introduction processes, equipment validation, revalidation, repairs, planned preventative maintenance (PPM), Permit to work (PTW).
To provide Outsourced Activity management of contractors e.g. supplier approval of contractors, Quality Technical Agreements, Monitoring of outsourced activity reporting system and supplier review.
To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to New Product Introduction and act as the Quality Risk Management (QRM) lead for process design e.g. Critical Process Parameters (CPP) / Critical Quality Attributes (CQA) and Product Quality Reviews (PQR).
Person specification
Qualifications
Essential criteria
- Degree in relevant scientific discipline or relevant experience.Or 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 Professional 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)
Desirable criteria
- Management qualification
- Professional Registration
Experience
Essential criteria
- Post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance.
- Experience of Quality Risk Management (QRM)
- Experience in the management and maintenance of pharmaceutical quality systems. Such as: Deviations, Change Control, Root Cause Analysis, CAPA, Quality Risk Management, Complaints, Recall, Supplier approval and management of outsourced activity.
Desirable criteria
- Experience of New Production Introduction management
- Experience in manufacture of sterile medicines
- Knowledge of or experience in coaching and mentoring practices and tools
- Knowledge of or experience in Quality improvement tools, techniques and methods.
Employer certification / accreditation badges
Documents to download
Further details / informal visits contact
- Name
- Rachel Ronaldson
- Job title
- QA Validation Manager
- Email address
- [email protected]
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