Do you want to work in one of the best performing NHS organisations in England? Work for an organisation that was voted the best acute and combined acute and community trust in the country, based on the experience of its staff (NHS Staff Survey 2022). Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn’t, this is what you get when you work for Northumbria Healthcare and, this is…the Northumbria Way!
What the Northumbria Way means for you:
* Extensive staff health and well-being programme including access to our specialist Wellbeing Hub
* Support and connection through a variety of Staff Network groups
* A range of flexible working opportunities
* Generous annual leave and pension scheme
* Access to lease car and home electronics scheme (qualifying criteria applies)
* Opportunities to improve your professional development through our vast training programmes
* On-site nursery places via salary sacrifice
* Access to savings scheme via salary sacrifice with Northumberland Community Bank
We are proud to be one of the country’s top performing NHS trusts – rated ‘outstanding’ overall by the Care Quality Commission (CQC). We provide a range of health and care services to support more than 500,000 people living in Northumberland and North Tyneside across the largest geographical area of any NHS Trust in England. Our teams deliver care from hospitals, a range of community venues and people’s homes. Our hospitals include a specialist emergency care hospital (the first of its kind in England), three general hospitals and community hospitals. In the community we deliver a wide range of community and public health services.
If Northumbria Healthcare sounds like somewhere you could belong we would love to hear from you. Visit our website to catch up on our latest news.
While Northumbria Healthcare is a highly innovative organisation, the use of Third Party Artificial Intelligence (AI) presents a risk to the integrity of our Recruitment & Selection processes. If you use AI, and it poses a risk to the integrity of your individual recruitment process, we may withdraw your application at any stage of the process.
Job overview
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.
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.
Working for our organisation
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.
Detailed job description and main 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 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 status 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 across organisational boundaries.
Person specification
Qualifications / Professional Registration
* Degree in Computer Science, IT, Pharmacy, or a related field, or equivalent experience.
* 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
* 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.
Applicants who are members of the Armed Forces, and those who have a disability that requires support in the workplace (two ticks pledge) and who meet the essential criteria will be interviewed under the Trust's interview guarantee scheme.
We recognise the positive value of diversity and inclusion and are committed to a workforce that is diverse, equal and inclusive. We welcome and encourage job applications from people of all backgrounds. We particularly welcome applications from Black, Asian and Minority Ethnic (BAME) candidates as BAME people are currently under-represented in our workforce as well as other under-represented groups such as LGBT+ and disabled candidates. We are proud to be a Disability Confident Employer, a Stonewall Diversity Champion, we have a Gold award from the Defense Recognition Scheme, and we are delighted to support Apprenticeships, Age Positive and are a mindful employer.
If you require any reasonable adjustments to attend interview please make the recruitment team aware as soon as possible by calling our HR Recruitment Team on 0191 203 1415 option 2.
Applicants who meet the Fit and Proper Person Requirements (FPPR) will require additional pre-employment checks in line with CQC and NHS England statutory guidance.
Make sure to read the ‘applicant guidance notes’ before submitting your application and make sure you know everything there is to know before joining our fantastic trust!
Please note that it is a requirement of this Trust that all successful applicants pay for their own DBS certification if a DBS check is required for the post. The method of payment is a salary deduction from your first monthly pay.
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