- To review executed batch records and to release the batch along with necessary entries in SAP.
- Responsible for stage wise review of electronic data parameters, review by exception and sign in to software wherever applicable.
- To review SOP related to manufacturing area and ensure compliance.
- 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.
- To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms and events as per site SOP.
- 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.
- To perform random checking desktop policy and to ensure housekeeping of system and area.
- To review and approve impact assessment of change in parameters.
- 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.

📌 Quality Assurance Officer (Baddi)
🏢 Zydus Lifesciences
📍 Baddi