compliance with cGMP guidelines and manage change controls and NCRs Address facility issues and risks quality risk management Manage deviations, change controls, and CAPAs Drive quality objectives and ensure
compliance with cGMP guidelines and manage change controls and NCRs Address facility issues and risks quality risk management Manage deviations, change controls, and CAPAs Drive quality objectives and ensure
microbiological testing. Opening of OOSs, deviations and change controls. Reporting issues to the QC Manager Calibration microbiological concern such as risk assessments and change control or deviation, under supervision of the QA pharmacist
microbiological testing. Opening of OOSs, deviations and change controls. Reporting issues to the QC Manager Calibration microbiological concern such as risk assessments and change control or deviation, under supervision of the QA pharmacist
GMP training. Documentation Control Ensures change control procedure is managed and controlled according
GMP training. Documentation Control Ensures change control procedure is managed and controlled according
trends to improve contractor quality compliance. Change control: Assess product related change proposals from timing of implementation of change at the contractor. Deviation control: Independently evaluate the impact
trends to improve contractor quality compliance. Change control: Assess product related change proposals from timing of implementation of change at the contractor. Deviation control: Independently evaluate the impact
manage, quality management of change (QMOC) process Instutute controls for raw materials, packaging and
measures and recommend changes Maintain risk registers Communicate risk control and risk management information