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QA Validation Specialist
The closing date is 03 September 2025
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.
About us
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.
Job 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 NewProduct 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
* 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)
* Professional Registration
Experience
* 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.
* 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.
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.
Northumbria Healthcare NHS Foundation Trust
Full-time,Flexible working,Compressed hours
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