Generation and Approval of Glasswasher Maintenance Procedure
- One (1) Cleaning Cycle/Recipe
- Two (2) Load Patterns
Equipment/Instrument Criticality Assessment
- Calibration of Critical Equipment
• Generation and Approval of Commissioning Protocol
• Execution of Commissioning Protocol / Discrepancy Generation and Resolution
• Generation/Approval of Commissioning Final Report
• Execution of Vendor Installation/Operation Qualification I/OQ
• Generation and Approval of Supplemental I/OQ protocol
• Execution of I/OQ Protocols / Discrepancy Generation and Resolution
• Generation/Approval of I/OQ Final Report
Generation of Cleaning Verification Protocol
- Manual Soiling of Glasswasher Equipment with worst case soil
- 1X Cleaning Verification for all Load Patterns
Laboratory Equipment Qualification experience in a GMP environment, Change Control, URS, IQ, OQ, and Requalification.
Bachelor's Degree in relevant field. 2-4 relevant experience in a GMP environment.
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