Pharmacy Quality Assurance and Control Assistant

Job overview

Hi, my name is Daniel Green, and I'm the Deputy QA manager. 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 form part of a small dedicated Quality service provided to  Radiopharmacy; which holds an Manufacturing Specials (MS) Licence and is regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA), Clinical Trials Aseptic Unit; which manufactures under an exemption of the Human Medicines Regulations 2012, and provides further Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidance to other sections within the Pharmacy Department at the Oxford University Hospitals NHS Foundation Trust.

Main duties of the job

The role will primarily involve the undertaking Quality Control Testing and Environmental Monitoring and validation protocols,  undertaking microbiological analysis of environmental monitoring samples, data entry, documentation control and management, producing reports, and assisting the QA Manager and Deputy in providing the QA and QC service to service users within and outside of the Trust.

Detailed job description and main responsibilities

• 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.
• Implement the environmental monitoring programme for the Licensed Radiopharmacy, unlicensed Clinical Trials Aseptic Service Units, Sterile Services facilities and other environmental monitoring as required.
• Undertake environmental monitoring. Undertake viable and unviable contamination monitoring of GMP Graded Clean Rooms.
• Implement validation protocols. Complete and coordinate testing.
• Implement principles of Quality Risk Management.
• 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.
• 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
• 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.
• Incubate and process environmental monitoring samples. Read plates as required and interpret against GMP environmental limits.
• Perform data processing of data onto spreadsheets and generation of documentation from data.
• Preparation of reagents, analytical solutions and other materials required for use in the QC laboratory.
• Sample and test instrumentation used within sterile services.
• Assist with equipment and facilities servicing and repairs.
• Maintain quality related documentation in compliance with GMP standards.
• Implement the Documentation Control activities for Quality and Production.
• Update and write standard operating procedures (SOPs) and validation protocols for activities relevant to the role.
• Participate in training students, pre-registration pharmacists and other staff assigned to work in the QC Department.
• 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 Quality Assurance Manager and defined by regulatory guidance.
• Interpret Out of Specification (OOS) results and escalate accordingly.
• Participate in Internal Audits, MHRA Inspections, and Regional and National QC Audits.
• Such other duties and/or developments as may be required and directed by the Head of PQA or Deputy QA Manager.