Experience

MMR Consulting

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Validation & Project Specialist

  • Mar 2019 - Present



Dalton Pharma Services

• Canada
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Validation specialist

  • Apr 2008 - Present

  • Established validation master policies and related SOP's (sterilization, water treatment, equipment, computerized systems). • Created, updated and implemented validation protocols, quality risk assessments and other QC and QA related documentation to meet cGMP requirements for ISO Class 5 – Class 8 clean room environment. • Developed and executed protocols to validate sterilization parameters of various product loads using Kaye Validator and Biological Indicators. • Supported and maintained Building Monitoring System (Yokogawa) performed environmental analysis and trends. • Executed IQ/OQ/PQ protocols and Periodic Performance Verification procedures for qualification of analytical and production equipment. Show less