An exciting opportunity has arisen for a QA Computerised Systems Validator to play a key role in ensuring compliance with EU GMP at the Medicines Manufacturing Centre (MMC).
As a QA Computerised Systems Validator, you will be the subject matter expert for implementing computerised system validations (CSV) within the MMC, ensuring all computerised systems within the MMC comply with regulatory requirements and best practices.
You will be instrumental in ensuring the facility, equipment, and processes meet the highest validation standards. Your work will directly impact regulatory compliance, operational efficiency, and product quality, ultimately benefiting NHS patients.
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.
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.
* You will be responsible for maintaining all computerised systems within the MMC, ensuring compliance with EU GMP and regulatory requirements.
* Lead the implementation and management of computerised system validations (CSV) within the MMC, ensuring compliance with EU GMP Annex 11 and 15.
* Collaborate with project teams to compile user requirements and specifications for computerised systems.
* Apply Quality Risk Management (QRM) principles to ensure systems maintain validated status throughout their lifecycle.
* Manage software version updates and revalidation, minimizing operational impact while maintaining compliance.
* Act as Data Integrity (DI) lead, ensuring compliance with GxP data integrity guidelines and developing a DI strategy for the MMC.
* Plan and execute user training for computerised systems, manage user accounts, access controls, and provide issue resolution support.
* Oversee outsourced software suppliers and provide CSV insights during internal and external audits/inspections.
* Support continuous improvement efforts in systems critical to production, quality control, and patient care while promoting a culture of innovation.
For further details / informal visits contact: Name: Carly McGurty Job title: Deputy Head of Quality Email address: Carly.McGurty@nhs.net
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