Senior Officer - Quality Assurance

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Job Responsibilities:

• Monitoring:
• In-process monitoring 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’s.
• 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 for 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 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 Bulk Tablets/Capsules as per respective SOP.
• Inspection of the Finished Goods inspection 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.
• Ensure sampling of in-process finished product, process validation, cleaning validation, control samples, EU Lab testing samples & stability samples 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.
  

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