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.

Source link