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Quality Assurance Facilitator
| Posting date: | 05 June 2024 |
|---|---|
| Salary: | £35,392.00 to £42,618.00 per year |
| Additional salary information: | £35392.00 - £42618.00 a year |
| Hours: | Full time |
| Closing date: | 30 June 2024 |
| Location: | Oxford, OX3 7DX |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9267-24-1312 |
Summary
Quality Assurance in Research and Development The post holder is expected to, Implement and maintain the systems which provide assurance of the quality ofclinical research activity undertaken within the Trust. Recognise and respond to research governance and quality issues that might ariseduring quality control checks. Participate in the hosting of regulatory inspections and audits as required. Promote a Quality Culture among R&D staff, users and the wider clinical research community. Act as local administrator and lead user of key Quality Assurance software in R&D, and as the local expert and primary liaison with Trust IT and the software vendor for these systems. The post holder will ensure that all systems meet the operational needs of the R&D at all times and will be responsible for the development andvalidation of associated systems and processes as required by the QA Manager. Document Management Take responsibility for developing the R&D portfolio of quality documents includingSOPs, Work Instructions, supporting Templates etc., in conjunction with the subjectmatter experts (authors) as appropriate under the direct supervision of the QAManager. Manage change, implementing new and updated working practices within R&D andensuring they are appropriately documented. Ensure that all Regulatory, and Trust requirements are encapsulated in the QualitySystem. Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors ondemand. Audit Implement the R&D systems audit programme to ensure that the Quality System isbeing implemented appropriately and fit for purpose. Recognise and act upon departures from legislative and research governancerequirements including failure to follow protocols and /or SOPs, respondingappropriately and escalating action as required. Participate in Good Clinical Practice audits of research studies running in the Trustand on as part of the audit programme implemented by the QA Manager. Accreditation Develop and maintain expert knowledge of any accreditation requirements andassociated guidelines, and how they apply in the R&D operational context shouldthey be required, e.g. MHRA phase 1 accreditation or Work closely with high-level stakeholders across the department and within researchteams to implement the plan for maintenance of any required accreditation underthe supervision of the QA Manager. Maintain oversight of risks of any accreditation programme undertaken. Produce regular reports for the Senior R&D management team to communicate progress with the maintenance plan and escalating risks as appropriate. Sample Processing Laboratories The post holder will work closely with lab leads, providing quality assurance support to ensure that the Research laboratories are compliant with relevant standards and legislation including HSE & ACDP Guidance, COSHH regulations, GCLP etc. Information and Data Management The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and R&D specific software in order to undertake theirduties. The post holder will collate and present routine quality information in a timely andaccurate manner to agreed formats and timescales ensuring that clear interpretationhave been made. They will use the Trust reporting systems and AMAT the trust auditing software They will ensure that all paper-based systems are maintained securely. They will oversee the storage and archiving of records in accordance with therelevant procedures and requirements. General The post holder will maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of clinical research. They will act as the R&D QA expert on quality matters pertaining to clinical trials. Attend national meetings on behalf of the service. Possess excellent communication skills, allowing the post holder to justify theirdecisions and influence others, communicating effectively and calmly in difficultsituations. Maintain good working relationships with academic and service departments topromote effective teamwork. Be able to work autonomously always adhering to departmental operatingprocedures and protocols.