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QA Officer
| Posting date: | 04 April 2025 |
|---|---|
| Salary: | £53,149 to £62,422 per year |
| Additional salary information: | £53149 - £62422 a year |
| Hours: | Full time |
| Closing date: | 21 April 2025 |
| Location: | London, SE1 7EH |
| Company: | NHS Jobs |
| Job type: | Contract |
| Job reference: | N0067-25-0004 |
Summary
Support the Head of PERL in maintaining the PERL facility and supporting GMP documentation in an MHRA audit ready state. Provide document control for Standard Operating Procedures, Batch Manufacturing Records and Validation protocols. Undertake regular review of logs for Micro, Physical and Cleaning Records of the PERL. Assist with the preparation and review of manufacturing and validation documentation such as Production and QC batch manufacturing records. Lead and act as a QA reviewer and approver for manufacturing and validation documentation, OCC, Dev, CC, CAPA and production records representing the GMP facility Act as a point of contact between PERL QA and the PET radiochemistry team. Lead internal QA audits ensuring that GMP compliance is met. Support the hosting of external audits by regulatory bodies. Ensure that the data for the QRM review of OCC, Dev, CC, CAPA, Audit actions/findings, document control/review, training records, EM review, Trending and Maintenance log review are fully documented and available at the time of the QRM. Support PERL management quality awareness by bring to their attention significant trends and issues via periodic reporting. Identify and assess any non-compliance issues, raise issues with senior/line management and ensure appropriate actions are agreed, implemented and followed up. Be proactive to ensure that regulatory and compliance issues are resolved in a timely manner and do not present barriers to the production of radiotracers. Provide advice and guidance on GMP, regulatory and compliance related issues. Provide GMP training. Research and analyse information from multiple sources in relation to updates to GMP regulations, with a view to amend/modify procedures and interventions in the manufacturing process within PERL. Participate and lead in process improvements utilising LEAN principles based on views from users and conveying the detail and rationale in a clear way Be proactive in providing quality support for the implementation of new radiopharmaceuticals to the PERL. The post holder will be required to work with minimum supervision. They must be able to manage their own time and workload efficiently and effectively. This also requires a confidential and methodical approach with a flexible and adaptable work ethic. They will interlink with other areas of the PET Centre and research groups within the School of Biomedical Engineering and Imaging Sciences and will be required to communicate with them effectively. The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.