matthew downie

Conducted a range of microbiology tests in a UKAS accredited microbiology laboratory, developing GLP skills

Supported cGMP manufacturing operations by prioritising qualification schedule to meet demands of production time-lines. Qualified a range of manufacturing equipment (including a tablet press and blister packer) for several concurrent projects, as part of validation improvement plan, in readiness for regulatory inspections. Presented equipment qualification packages during successful MHRA and FDA inspections. Qualified GMP clean room facilities and HVACs including arranging and supervising service visit with third party company to conduct air velocity / air change rates, filter integrity testing and air flow visualisation studies. Conducted temperature and relative humidity mapping studies for cleanrooms and warehouses and temperature mapping studies for fridges and freezers. Analysed data from mapping studies to determine requirements for continuous temperature (and relative humidity) monitoring.

Manufacture of sterile pharmaceutical products (including vials, bags, syringes, eye drops and freeze dried formulations) in a Grade A clean room. Gained experience in GDP and knowledge of working within quality system. Wrote change controls, SOPs and conducted deviation report investigations. Conducted air cleanliness testing to ISO 14664 guidelines Organised shutdowns for facility/utility/equipment maintenance/calibration and requalification, minimising cleanroom downtime. Including scheduling and arranging service visits with third parties. Wrote and executed qualification protocols for equipment including a porous and fluid load autoclaves and dry heat sterilising oven (using thermal validation software TQSoft).