Responsible for daily work allocation to the analysts and execution.
- Handling of OOS, OOT, incidents, deviations and change controls etc.
- Monitoring stability chambers and compliance.
- Review and releasing of stability reports, data trending and compilation without delay.
- Review and releasing of finished product and In-process without delay.
- Preparing and execution of stability protocols, method transfer protocols, cleaning validation protocols and other miscellaneous protocols.
- Review and releasing of finished product and In-process without delay.
- Guiding tothejuniorsinIPaspects, monitoringtheirprogress and audit compliance.
- Preparingresponse forthe customer complaints of QC related issues.
- Conducting training to the analysts and qualifying them for routine lab activities.
- Accountability for the overall QC activities and compliance.
- Responsibility for IQ, OQ and PQ.
- Responsibility for handling of control samples and periodic review.
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