We are seeking an enthusiastic and committed individual to join the Oxford University Hospitals NHS Foundation Trust Pharmaceutical Quality Assurance and Quality Control team as Pharmacy Quality Assurance and Control Assistant.
The post holder will be part of a small dedicated Quality service provided to Radiopharmacy, which holds a Manufacturing Specials Licence and is regulated by the MHRA, as well as to an unlicensed Clinical Trials Aseptic Unit. The role will primarily involve quality control testing, environmental monitoring, validation protocols, microbiological analysis, data entry, documentation control and management, report production, and assisting the QA Manager and Deputy in providing QA and QC services to internal and external service users.
Responsibilities
1. Provide support to the head of PQA and Deputy. Work with QA and QC Technicians to maintain and develop the in‑house QA and QC service.
2. Implement the environmental monitoring programme for the Licensed Radiopharmacy, unlicensed Clinical Trials Aseptic Service Units, Sterile Services facilities and other environmental monitoring as required.
3. Undertake environmental monitoring, including viable and unviable contamination monitoring of GMP graded clean rooms.
4. Implement validation protocols. Complete and coordinate testing.
5. Implement principles of Quality Risk Management.
6. Assist with investigation, identify CAPAs, and assist with close‑out of deviations, non‑conformances, environmental out‑of‑specifications (OOS), testing OOS, customer complaints and trust incident reports.
7. Undertake accurate record keeping as described in the Pharmaceutical Quality System, ensuring completion of all production documentation to provide a complete audit trail for all manufactured/dispensed products. This includes providing regular updates on aspects of the PQS status for Radiopharmacy and OxPQAs.
8. Support the maintenance of an acceptable sterility assurance programme by providing appropriate advice and applying expertise while carrying out routine testing, processing of microbiology samples and in the design and execution of validation protocols.
9. Incubate and process environmental monitoring samples. Read plates as required and interpret against GMP environmental limits.
10. Perform data processing of data onto spreadsheets and generation of documentation from data.
11. Preparation of reagents, analytical solutions and other materials required for use in the QC laboratory.
12. Sample and test instrumentation used within sterile services.
13. Assist with equipment and facilities servicing and repairs.
14. Maintain quality related documentation in compliance with GMP standards.
15. Implement the Documentation Control activities for Quality and Production.
16. Update and write standard operating procedures (SOPs) and validation protocols for activities relevant to the role.
17. Participate in training students, pre‑registration pharmacists and other staff assigned to work in the QC Department.
18. Work unsupervised on occasion following strict testing regimes or protocols. The post holder will be expected to decide on the best way to utilise their time and the resources available in carrying out work instructions, validation protocols and laboratory procedures while ensuring that these are completed to the required time and standards as agreed to by the QA Manager and defined by regulatory guidance.
19. Interpret out‑of‑specification (OOS) results and escalate accordingly.
20. Participate in internal audits, MHRA inspections, and regional and national QC audits.
21. Perform other duties and/or developments as may be required and directed by the Head of PQA or Deputy QA Manager.
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