QA Validation Specialist

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

1. Develop and manage the Validation Master Plan (VMP) and oversee new equipment introduction, validation, and revalidation.
2. Lead Quality Risk Management (QRM) activities for process design, ensuring Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) are effectively managed.
3. Provide QA oversight of Process Validations, including Aseptic Process Simulation (APS), operator validation, gowning validation, and cleaning validation.
4. Manage outsourced activity, including supplier approval, Quality Technical Agreements, and contractor oversight.
5. Oversee the Contamination Control Strategy (CCS) and environmental monitoring program in collaboration with the Site Microbiologist.
6. Support QA capacity planning and oversee unit crisis management procedures and site shutdown planning.
7. Deliver QA system training across MMC to ensure compliance and staff competency.
8. Promote continuous improvement and innovation to enhance quality, compliance, and operational efficiency.