QA Validation Specialist | Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust
| Posting date: | 14 April 2025 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £46,148 - £52,809 per annum |
| Hours: | Full time |
| Closing date: | 14 May 2025 |
| Location: | Seaton Delaval, NE25 0QJ |
| Company: | Northumbria Healthcare NHS Foundation Trust |
| Job type: | Permanent |
| Job reference: | 7032048/319-7032048JN |
Summary
An exciting opportunity has arisen for a QA Validation Specialist to play a key role in ensuring compliance with EU GMP at the Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC is a state-of-the-art NHS facility dedicated to the sterile manufacture of injectable medicinal products.
Operating under MHRA Good Manufacturing Practice (GMP) standards, the MMC ensures a secure supply chain for Systemic Anti-Cancer Therapy (SACT) products, while delivering Ready-to-Administer (RtA) medicines to enable nurses to spend more time on patient care.
As a QA Validation Specialist, you will be responsible for managing all validation activities, ensuring equipment, processes, and systems comply with regulatory requirements and best practices.
Working at MMC
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 unique opportunity to be part of a pioneering NHS facility, ensuring that MMC becomes a leader in aseptic manufacturing, validation, and regulatory compliance. If you are passionate about quality assurance, validation, and making a difference in patient care, we would love to hear from you.
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.
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.
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).
This advert closes on Monday 28 Apr 2025
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