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QA Computerised Systems Validator
| Posting date: | 04 March 2025 |
|---|---|
| Salary: | £46,148.00 to £52,809.00 per year |
| Additional salary information: | £46148.00 - £52809.00 a year |
| Hours: | Full time |
| Closing date: | 18 March 2025 |
| Location: | Seaton Delaval, NE25 0QJ |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9319-25-0248 |
Summary
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.