A highly experienced Senior Operator, with seven years’ experience as a Manufacturing Technology Engineer, with extensive experience in Process Development, Clinical Trial Manufacturing, Medical Device and Pharmaceutical Manufacturing & Packaging.In my current role at Almac Pharma Services I manufacture solid dose development and GMP batches, setting up manufacturing processes across multiple processing rooms, at the appropriate scale of manufacture in either an un-contained or contained manufacturing environment.In my previous role, I was a member of a Manufacturing Technology Team; where I focused on technical support to commercial manufacturing and packaging operations.I have conducted process development and clinical trial manufacture, providing manufacturing and technical support to product formulation teams in the R&D environment.In my career I have contributed to the successful development and manufacture of the phase 3 clinical trial supplies for Symbicort® pMDI and ticagrelor tablets (Brilinta®) with AstraZeneca. As well as delivering the successful Performance Qualification of the Cavilon® No Sting Barrier Film Wand Peel Sachet product, achieving the successful regulatory approval and release of product from the 3M Loughborough site in 2019.I have contributed to the development business by leading the training of staff in various technology areas which improved knowledge, flexibility, quality and service. I generate Work Instructions, Standard Operating Procedures, Manufacturing Batch Records and Process Deviation documentation to support the business needs.I manage Engineering Control Controls and investigate Quality Incidents, impacting product quality, so not to affect the release of products to the market.My Core Competencies include:• Clean Room and GMP Trained• Generation of GMP Documentation• Change Control & Process Deviation Management• Quality Incident Investigations• Equipment and Process Risk Assessment Management• Generation of Validation Protocols• The Validation of Pharmaceutical and Cleaning Processes• SAP training• Lean and Green Belt trainingAvailable to discuss new and exciting opportunities in the Midlands area.
