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Charleston, South Carolina Area United States

Director of Technical Services and KAM Program at Commissioning Agents, Inc

Medical / Health Care / Pharmaceuticals

Commissioning Agents: Major Services Facility Commissioning, Validation, and Start-up • Commissioning and validation planning • Risk assessments • Commissioning project management • Factory acceptance testing • Commissioning procedures, inspection and test forms • Equipment and system installation inspections • Start-up and troubleshooting • Commissioning testing • Validation protocol writing • Protocol field execution and reports • Computer validation, cleaning validation, sterilization validation, product validation Life Cycle Software Development and Validation • Requirements and specification development • Design documentation • Quality assurance/ validation