Job Description

The Quality Assurance/Quality Control Department is part of the Pharmacy Preparative Services Department which also consists of the Pharmacy Manufacturing Unit, all aseptic dispensing units and Radiopharmacy. The Quality Assurance/Quality Control service operates across several Trust sites; primarily in support of Preparative Services including the licensed Aseptic Production Unit (APU) and Dispensary Support Unit (DSU) at Moor House. However, the service extends throughout Pharmacy and also provides support to other departments outside Pharmacy and to external Trusts and the private sector. The post is based in the QC/QA department at Moor House although the post holder will be required to travel to all Trust sites and to external customers when necessary.



Working with highly specialist equipment and devices in potentially high risk areas requires the post holder to possess a quality focus and an eye for detail to ensure all test results are accurate, precise and reproducible. The sometimes unpredictable nature of the workload requires an individual who is flexible and can remain calm and efficient when working under pressure. The individual must be able to work well within the team but also show initiative, good time management and commitment when working on their own. The post holder will participate in a variety of quality control testing duties within the pharmacy QA/QC service.



These will include clean room monitoring (physical and microbiological), environmental monitoring, analytical testing of samples, finished product checking and analysis of products manufactured in the licensed manufacturing and repackaging units and the quality assessment of medicines procured by the Trust. This will involve the use of a variety of specialist testing techniques and equipment both within the QC laboratory and on location, both within the Trust and for external customers. The postholder will act as a designated quality controller for piped medical gas testing within the Trust and to external customers. The post holder will also participate in training sessions and in clerical tasks such as report writing.



The post holder will not have any line management responsibilities. The post holder will be responsible for day to day co-ordination of equipment planned preventive maintenance and remedial action within QA/QC and in support of the APU, DSU and Aseptic Services managers. They will be required to induct and train staff working with associated equipment and devices. Principle Duties and areas of responsibility include: To be responsible for the day to day management of equipment and clean room device maintenance and testing.

This will include:

- Planned preventative maintenance - Equipment calibration - Troubleshooting and Remedial action - Maintaining an equipment & device fault register and prioritising workload. - provide reports and recommendations to the QC team leader - stock control of QA/QC equipment consumables - Liaison with external service contractors and witnessing of validation, maintenance and testing. - Advising Clean room leads on day to day device use, care and maintenance - participation in service review and development - training of Pharmacy Clinical Support Services staff in SOPs related to device use, care and maintenance To act as a senior quality controller (MPGS) for medical gas testing. - High hazard work - Commissioning new installations - Troubleshooting - Supervision of other staff working within the medical gas testing service.



Performs the following core duties according to clearly defined procedures: - Sterility testing using aseptic techniques - Microbiological sampling in clean room areas - Processing microbiological monitoring samples - Physical environmental monitoring of clean rooms and clean air devices - Medical gas testing - Analysis of products manufactured in the licensed production unit - Inspection of finished products from licensed manufacturing units (Repackaging and aseptic production) - Analysis of raw materials - Quality assessment of medicines procured by the Trust (unlicensed medicines, raw materials, excipients and regional contract support) - Reporting of minor product defects (medicines and consumables) - Temperature monitoring and trend analysis of medicines storage - Chemical exposure monitoring - Utilizing pharmacy stock control systems - Report writing - Collation of activity figures Other duties as directed by the QC Team Leader.