Support analysis and report micro testing result and trend. Provide timely feedback to area owner if abnormality observed. Perform periodical evaluation on Micro related program (e.g. Environmental Monitoring, utilities monitoring and product/raw material monitoring.
Support investigation for any Microbiology Out-Of-Specification (OOS) excursion.
Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.
Perform a spot-check of activities for the oversight areas to ensure compliance with quality standards.
Ensure adherence to frequency of oversight mandated in the Quality oversight schedule.
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