Quality Assurance Officer

1) To review executed batch records and to release the batch along with necessary entries in SAP.

2) Responsible for stage wise review of electronic data parameters, review by exception and sign in to software wherever applicable.

3) To review SOP related to manufacturing area and ensure compliance.

4) To review respective manufacturing log books (for e.g., area cleaning logbook, equipment usage logbook) and environmental monitoring records (for e.g., temperature and humidity logbook) and to ensure contemporaneous documentation.

5) To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms and events as per site SOP.

6) To review formats used for recording of parameters during operation in case of any change/ alter/ modification in the PLC/HMI/MMI and audit trails print out at the time of Batch release for transfer to packing or release for dispatch.

7) To perform random checking desktop policy and to ensure housekeeping of system and area.

8) To review and approve impact assessment of change in parameters.

9) To support investigation of the deviation/incidences, non-conformances, market complaint, OOS (Phase II- Process Investigation) and to verify the CAPA proposed in the area of operation.