Department Details

Role Summary

To Carry out investigations on the Laboratory Incidents, OOC, OOS, OOT, Deviations and Incidents.

Key Responsibilities

To Carry out investigations on the Laboratory Incidents, OOC,OOS,OOT, Deviations and Provide CAPA as applicable. Responsible to investigate the incidents / deviations occurred across the lab during analysis. Ensuring CAPA effectiveness& verification for the implemented CAPA. Responsible for the preparation/review of change controls in Quality Control. To prepare and review of investigation reports, risk assessments, impact assessments protocols and reports (Hypothesis, method validations, transfers and qualification) as applicable. Responsible to Preparation/review the Certificate of Analysis. Initiation of Laboratory Incidents, OOC,OOS,OOT, Deviations. Responsible to Preparation/review Standard operating procedures/Instrument operating procedures. Revie...