Title: Trainee Officer

Responsibilities:

• Ensure compliance to cGMP for all operational activities.
• Monitor the formulated products against stipulated conditions mentioned in the batch production record.
• Conduct certification of batch production records for compliance and stage-wise completion.
• Conduct line and area clearances.
• Conduct annual review of product quality.
• Conduct calibration of IPQA laboratory instruments.
• Give required support during validation studies.
• Assist with deviations, complaint handling and investigations.
• Sampling of water, intermediates, finished products, environmental monitoring etc.
• To verify and approve over printed packaging components (Batch coding approval).
• Collection of control samples, stability samples, shipment samples and any other samples.
• Review of control samples.
• Monitoring of cGMP compliances at Warehouse.
• Equipment & area line clearance in Warehouse.
• Environment monitoring of dispensing and sampling area of General Warehouse.
• Sampling and monitoring of purified /potable water in General Warehouse.
• Collection of In-process / stability/validation samples.
• Beta Lactam Containment Monitoring in warehouse.
• Review and approve of equipment qualification documents for accuracy, completeness and traceability as well as adherence to protocol /procedures pertaining to Warehouse.
• To ensure compliance of the audit observations of Warehouse.
• Co-ordinate with Warehouse for handling quality related issues and provides guidance for timely resolution of quality issues.
• Verification of return finished goods form different location.
• Approval of shipper labels.
• Approval of MDN.