Mohammad Mustaq Bijapur

Computer System Validation Engineer @Joinn Biologics Us Inc

Qualifying GMP Facility SCADA system – Heating, Ventilation and Air Conditioning (HVAC) system. Qualifying SCADA system controlling and monitoring GMP equipment including Bioreactors & 200L), Process Gases Distribution system, Pure Steam Generation & Distribution system, Purified Water system, WFI Generator & Distribution system, Depyrogenation Oven, CIP Portable, CIP Skid, Lancer Washer, Air compressors, Air Dryers, freezers, incubators and refrigerators, cold rooms and autoclaves. Author, Review and Execute technical protocols (Installation, Operation & Performance) for the validation of SCADA systems. Validating Equipment Calibration and Preventive Maintenance application system to implement automated calibration and maintenance program. Validating Syberworks system to implement Electronic Document Management system and Learning Management system. Validating Enterprise Resource and Planning application system to implement Electronic system to automate Warehouse Management System, Manufacturing module, Procurement & Order Management modules meeting business requirements and specifications dictated by the Code of Federal Regulations, Title 21 CFR Part 11, 21 CFR Part 211, Quality Control and Quality Risk Management and 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. Author & Review Validation deliverable documents including Validation Plans, User Requirements, Functional Specifications, Software Design Specifications, Hardware Design Specification, Configuration Specifications, IOQ Protocols, Commissioning Protocols, Data Migration Protocols, Traceability Matrix, Risk Assessments and Validation Summary Reports. 8.Perform System Impact, Criticality Impact assessments & Risk Assessments for the GxP systems.