AMDM - QA

To Perform shop floor compliance to cGMP and GDP and facility/equipment up keeping.
As a Section QA Role in Track wise to Perform Activates like Preliminary Investigation Interrogation with Persons related to deviation approval of change controls Initiation of change controls and implementation of CAPA.
Initiate review and perform the investigation of Deviation logged by user departments by suitable investigation tool and to identify the root cause for reported deviations.
To release the batches in SAP .To release job order related to Machine Breakdown and approvals after completion of Maintenance work in SAP.
To review and to evaluate the impact of change controls initiated by user department related to Document product facility system equipments etc.
To perform and verify the challenge tests and inprocess test as per the requirement Of the batch process report validation (PVR).
To Prepare Annexure related to Line clearance AQLBMR/BPR Review sheets.
To perform sampling of intermediate samples semifinished samples process validation samples hold time study samples control samples