Description
includes setting up the first-of it's-kind private veterinary laboratory in the US starting the only methadone alternative drug manufacturer company and getting these GLP and GMP qualified authoring System Life Cycle documents (VP URS FRS DDS IQ OQ and PQ) pursuant with GMP 21 CFR 210 211 820 and Part 11 Part 11 Assessments and Gap Analysis Remediation Plans along with procedural remediation implementation (SOPs). Additional experience includes Medical Device manufacturing pursuant to ISO 13485. As director of laboratory services I maintained all QC data and reported to management current status of each batch and generated quality control charts for review of data which allowed for monitoring the quality of each batch and allowed the chief chemist to make any changes in the production process
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