⁃ All quality system:
⁃ Deviation
⁃ CAPA
⁃ Change control
⁃ Training
⁃ Calibration instrument
⁃ Internal audit
⁃ Supplier audit
⁃ Complaints and Recall
⁃ Product release for biopharmaceutical product and APIs.
⁃ Validation: Review and final approve validation/ qualification protocol and report (IQ, OQ, PQ and RQ) of;
⁃ Water system (Purified water, WFI, pure steam system)
⁃ Cleanroom and HVAC system
⁃ Compressed dry air system
⁃ Temperature mapping of Autoclave, Incubator, Coldroom, Refrigerators and Freezer
⁃ Process equipment (Bioreactor for upstream process, Mixing tank, Biosafety cabinet, Weighing balance and others.)
⁃ All quality system:
⁃ Deviation
⁃ CAPA
⁃ Change control
⁃ Training
⁃ Calibration instrument
⁃ Internal audit
⁃ Supplier audit
⁃ Complaints and Recall
⁃ Product release for biopharmaceutical product and APIs.
⁃ Validation: Review and final approve validation/ qualification protocol and report (IQ, OQ, PQ and RQ) of;
⁃ Water system (Purified water, WFI, pure steam system)
⁃ Cleanroom and HVAC system
⁃ Compressed dry air system
⁃ Temperature mapping of Autoclave, Incubator, Coldroom, Refrigerators and Freezer
⁃ Process equipment (Bioreactor for upstream process, Mixing tank, Biosafety cabinet, Weighing balance and others.)