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.