Job summary 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 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. 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. 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. Main duties of the job 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 About us 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. Date posted 04 March 2025 Pay scheme Agenda for change Band Band 7 Salary £46,148 to £52,809 a year per annum Contract Permanent Working pattern Full-time, Flexible working, Compressed hours Reference number 319-7030151JN Job locations Manufacturing and Innovation Hub Avenue Road Seaton Delaval NE25 0QJ Job description Job responsibilities To be the subject matter expert responsible for implementing computerised system validations(CSV) within the MMC. 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 ofEU 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 promoteownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries. Job description Job responsibilities To be the subject matter expert responsible for implementing computerised system validations(CSV) within the MMC. 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 ofEU 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 promoteownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries. Person Specification Qualifications / Professional Registration Essential Degree in Computer Science, IT, Pharmacy, or a related field, or equivalent experience. Desirable Certification in GMP compliance and computerised systems validation (e.g., GAMP5) or equivalent experience. Postgraduate qualification in Quality Assurance or Data Management Professional Registration Experience and knowledge Desirable Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment Demonstrated experience of computerised systems validation in accordance with EU GMP annex 11 Experience of developing and executing computerised systems and data integrity training to colleagues Demonstrated experience of working in sterile manufacture in accordance with EU GMP Annex 1. Evidence of participating within an MHRA Regulatory inspection Person Specification Qualifications / Professional Registration Essential Degree in Computer Science, IT, Pharmacy, or a related field, or equivalent experience. Desirable Certification in GMP compliance and computerised systems validation (e.g., GAMP5) or equivalent experience. Postgraduate qualification in Quality Assurance or Data Management Professional Registration Experience and knowledge Desirable Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment Demonstrated experience of computerised systems validation in accordance with EU GMP annex 11 Experience of developing and executing computerised systems and data integrity training to colleagues Demonstrated experience of working in sterile manufacture in accordance with EU GMP Annex 1. Evidence of participating within an MHRA Regulatory inspection 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Additional information 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Employer details Employer name Northumbria Healthcare NHS Foundation Trust Address Manufacturing and Innovation Hub Avenue Road Seaton Delaval NE25 0QJ Employer's website https://www.northumbria.nhs.uk/ (Opens in a new tab)