Job Description

• Monitoring:

• In-process monitoring and analysis of Manufacturing & Packing activities of Tablets and Capsules.

• Ensure compliance to cGMP Regulations, established SOPs, FO/MI and PO/PI and for all operational activities, area and equipment.

• Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell.

• Calibration & maintaining documentation of In-process Quality Assurance (IPQA) instruments.

• Data back-up activities of IPQA instruments as per defined SOP frequency.

• Monitor the environmental conditions mentioned in the batch production record and SOP.

• Certification of batch production records for compliance and stage-wise compliance.

• Reporting any GMP related discrepancies, non-conformances and deviations to superiors immediately.

• Collection and entry of data for APR preparation.

• Imparting training to team members and subordinates.

• Line Clearance:

• Ensure physically that the area and equipment to be used for manufacturing and packaging of next product/batch are free from any material/remnants of previous product.

• Ensure to prevent mix up and cross contamination.

• Check for proper environmental conditions with respect to temperature, Relative humidity, differential pressure etc.

• Ensure that the Batch Production record is completed up to the previous stage.

• Verify the material with respect to the container labels and quantity from the batch production record.

• In-Process Checks:

• Ensure the calibration of instruments for in-process checks.

• In-process checks as per the approved manufacturing and packaging instructions.

• Enclose all the printouts generated during in-process checks along with the batch production record.

• All printouts shall be duly signed after checking.

• Inform the production manager, supervisor and quality assurance manager about the in-process failure observed during in-process checks.

• To record all the observations in the Batch Production Record

• Inspection:

• Inspection of the Tablets/Capsules as per SOP.

• Inspection of the Finished Goods as per SOP and clearance of Transfer Ticket by ensuring the quantity and batch details.

• Sampling:

• Ensure for usage of appropriate sampling tool for sampling.

• Ensure sampling device cleaning prior to the sampling.

• Sampling procedure to be followed as per SOP No. SOP019995 (Sampling of intermediates, finished product and stability samples) & SOP020059 (Collection and shipment of Analytical samples of EU market).

• Ensure sampling of in-process finished product, process validation, cleaning validation, control samples, EU Lab testing samples & stability samples, Reference & Retention sample as per SOP.

• Approval:

• Approval of coding pattern on immediate pack and secondary pack to be verified as per the approved packaging instructions / written procedures.