QA Computerised Systems Validator

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 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.
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.
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
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 lead the validation, maintenance and management of all computerised systems within the Medicines Manufacturing Centre (MMC), ensuring compliance with Annex 11 and Annex 15 of
EU GMP, Pharmaceutical Quality System (PQS), regulatory standards, and Trust policies.
To work with project teams to compile user requirements specifications for computerised systems.
To provide a quality risk management (QRM) approach to CSV.
To ensure computerised systems maintain validated throughout their lifecycle, with periodic risk assessments and review.
To manage software version updates and subsequent revalidation using QRM, minimising impact to productivity / operation.
To act as Data Integrity (DI) lead on site, for processes, equipment and software, in compliance with MHRA Guidance on GxP data integrity.
To develop, implement and maintain a DI strategy for the MMC, DI risk assessment and DI training.
To plan and implement user training for on-site computerised systems, set up and manage user accounts, access control, permissions and be the point of contact for any issues.
To manage QA outsourced activity of software suppliers.
To provide a CSV perspective in both internal and external audits / inspections.
To support the quality assurance of systems critical to production, quality control, and release processes while fostering continuous improvement in alignment with NHS standards.
To contribute to the development of a culture of high engagement, where staff are empowered and entrusted to provide the best services and care for patients
To promote and facilitate innovation and continuous improvement to deliver better services for service users and patients.
To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote
ownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and