Vijay Kumar

• Provide expert assess/support to Production / QC and QA in sterility & contamination control strategy point of view, where I am a lead of Sterility Assurance, Key contact for all matters related to Sterility of Bulks, Final Fill Products includes Aseptic Process Simulations,/Media fills, Aseptic Practices, Environmental Monitoring, for clean rooms (viable and non-viable) certifying the aseptic operators and critical utilities, Surface Cleaning and Sanitization, Sterilization (including sterile hold time), container integrity, material transfer, bioburden / endotoxin, gowning, fogging and Sterility Failures, • Assure the adequate facilities contamination control practices monitoring tools are provided to Production to guarantee the best environmental monitoring indicators levels, including trends analysis interpretation, Challenge technical and scientific aspects of facilities design and aseptic principles with Technical & site services, QA, Production etc…