Steven Wafer

Senior Validation & Cq Engineer @阿斯利康

Liverpool, GB

Validation Service Provider for Purified Water System Upgrade (SAT, FAT, DQ, C&Q, IOQ & PQ)Witnessing and review of SAT & FAT Documentation. Providing C&Q Plans & Assessments, DQ, IOQ & PQ Protocol Preparation, execution and summary reports. Ensuring compliance to site Data Integrity and BAU (Business As Usual) Programmes.Validation Service Provider for (ACOS) Automated Centrifuge Offload System Upgrade, IOQ & PQ)Providing, IOQ & PQ Protocol Preparation, execution and summary reports. Ensuring compliance to site Data Integrity and BAU Programmes.Data Integrity Programme SupportSupporting the site Data Integrity Programme, Protocol Preparation, Mitigation and execution for the new and existing equipment. Review and formation of computerised systems documentation and associated mitigation actions following a risk-based approach.Validation Project SupportSupporting the site Validation Project Programme on various systems (See Below), Providing C&Q Plans & Assessments, DQ, IOQ & PQ Protocol Preparation, execution and summary reports. Ensuring compliance to site Data Integrity & BAU Programmes.Equipment includes:BSC’sPurified Water (UV Upgrade)HVAC/Room IOQIsolators Isolator Symbio PumpsInoculator (DSEAR Compliance Upgrade)Cold Store (Including Loaded Studies)Incubators (Including Loaded Studies)Freezers (Including Loaded Studies)Refrigerators (Including Loaded Studies)Centrifuge LN2 FreezerAll systems completed in accordance to site Data Integrity and BAU Programmes.Validation Service Provider for QC Monoclonal Antibody Laboratory (C&Q, IOQ)Validation Service Provider for QC Multi-Purpose Laboratory Upgrade (C&Q, IOQ)Providing C&Q Plans & Assessments, IOQ Protocol Preparation, execution and summary reports for the new QC equipment. Ensuring compliance to site Data Integrity and BAU Programmes.

Knowsley Community College

 City & Guilds 224 Part 1 & 2 Electronic Servicing and Instrumentation