Quality Assurance And Validation Engineer
Current- Created process flow diagrams using AutoCAD for the production lines of pharmaceutical products to aid in FDA inspections. - Requalified production equipment (reactor tanks, product mills), sterilization equipment (autoclaves, depyrogenation ovens), and requalified freezers/cold storages. - Participated in engineering studies on production equipment. - Used Microsoft Excel to conduct data analysis of SIP testing on depyrogenation ovens, autoclaves, and lyophilizers.- Routed GxP Equipment in Maximo to alert validation engineers of upcoming re-qualification requests- Drafted System Classification and Impact Assessment forms for equipment- Reviewed protocols and technical reports for errors and GxP compliance- Drafted technical reports analyzing effectiveness of sterility equipment