• Improve process capability where weaknesses are identified.• Support Media Simualtion activities and develop and maintain media fill strategy.• Visual inspection and Aseptic manufacturing SME • Write product/process impact assessments in support of investigation closures, as requested.• Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site… Show more • Improve process capability where weaknesses are identified.• Support Media Simualtion activities and develop and maintain media fill strategy.• Visual inspection and Aseptic manufacturing SME • Write product/process impact assessments in support of investigation closures, as requested.• Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site personnel.• Participate in Gap Analyses and Risk Assessments to support the tech transfer.• Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC• Scale up to commercial manufature of Drug Product from Engineering through to Process Validation batches • Raising and execution of change controls and committments for Technical Services• Provide process expertise for trouble-shooting and resolution of manufacturing process and technology issues. • Assess impact of regulatory changes and implement process improvements to ensure compliance is maintained Show less