Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust
About
Northumbria Healthcare NHS Foundation Trust is an award-winning NHS Foundation Trust which provides hospital and community health services in North Tyneside, and hospital, community health and adult social care services in Northumberland.
Key details
Location
Site: Manufacturing and Innovation Hub
Address: Avenue Road
Town: Seaton Delaval
Postcode: NE25 0QJ
Major / Minor Region: Tyne and Wear
Contract type & working pattern
Contract: Permanent
Hours: 37.5 hours per week
* Full time
* Flexible working
* Compressed hours
Salary
Salary: £46,148 - £52,809 per annum
Salary period: Yearly
Grade: (NHS AfC: Band 7)
Specialty
Main area: Medicines Manufacturing Centre
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.
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.
Advert
* 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.
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 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.
Person specification
Qualifications / Professional Registration
Essential criteria
* Degree in Computer Science, IT, Pharmacy, or a related field, or equivalent experience.
Desirable criteria
* 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 criteria
* 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.
Further details / informal visits contact
Name: Carly McGurty
Job title: Deputy Head of Quality
Email address: [email protected]
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