Skilled validation professional and laboratory manager with extensive background in and thorough knowledge of cGMPs, ICH guidelines, GAMP5, USP and the pharmaceutical industry in general. Experienced in managing challenging projects in the quality chemistry laboratory and software development/validation areas. Expert in the use and administration of Empower 2/3 including troubleshooting issues. Experience with validation of various types of equipment in laboratory and manufacturing areas. Exceptional analytical, troubleshooting, organizational, problem solving and managerial skills.
API, budgeting, CAPA, commodities, client management, DEA, HAZMAT, Waters Empower, FT-IR, GC, hiring, HPLC, Investigations, laboratory management, LEAN, KanBan, Microsoft Office, personnel, processes, protocols, quality, root cause analysis, safety, SAP, technical support, Trackwise, troubleshooting, UV, validation
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