Executive - Quality Assurance

2 weeks ago

Paonta Sahib, India Sun Pharmaceutical Industries Ltd Full time

**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.

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