Northumbria Healthcare NHS Foundation Trust
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.
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.
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 Product 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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