Microbiology Expertise, Sterility Assurance; (Steam, ETO and gamma)Set up Quality Systems, Medical Devices and Phamacuetical

Direct the activities of Quality Control labs and Quality Assurance Departments. Responsible for all validation activity including, tube and bottle filling lines as well as manufacturing tanks, mixers and other manufacturing equipment. Coordinate annual product reviews as well as a material review board to expedite the closure of outstanding non-conformance reports. Responsible for tracking corrective actions to assure they are effective.Troubleshoot problems in bulk manufacturing as well investigate trouble in the filling areas. Designed a new barrier to separate the filling heads from the down stream packaging lines.

Startup of the cGMP Microbiology Department. Wrote all the SOPs for water testing, sterility testing, endotoxin assay, microbial limit test, etc.Authored validation protocols for: IQ/OQ/PQ Incubators, Autoclaves, Stability Chambers. Also Clean Room Validation, based on USP <1116> and ISO 14644-2 &3 plus EU annex 1. Expert use of Kaye Validator. Created training programs for aseptic technique and for all other Microbiology tests.

Set up a cGMP Microbiology Department

Initiated a Quality Control Microbiology Department, including Environmental Monitoring, Sterility, Endotoxin, Particle Size, Bioburden, Water testing; TOC, Conductivity, Water Bioburden. Responsible for trouble shooting all problems with the aseptic processing plant.