Executive- QA (IPQA Injectable Plant)

<p>1. Preparation and review of the manufacturing and packaging Technical Direction.</p><p>2. Preparation of SOPs pertaining to In-Process QA.</p><p>3. Line Clearance during all critical process during Dispensing, Manufacturing, Filling & Stoppering and Packing operation.</p><p>4. Verify the dispensing of RAW Material and Packing Material.</p><p>5. In Process checking during dispensing , manufacturing, filling lyophillization, sealing, optical inspection, labeling and packing operation.</p><p>6. Sampling of process Validation Batches.</p><p>7. Sampling of In - Process and finished products and validation activities.</p><p>8. Collection of swab and rinse sampling after cleaning of equipment's and area.</p><p>9. Collection, Storage, Handling, Inspection and destruction of reserve samples.</p><p>10. Review Executed Exhibit and commercial Batch Manufacturing Records and packaging Record for release of finished Product.</p><p>11. To Monitor and verify any qualification of the process, equipment and system.</p><p>12. To Perform role of QA oversight and observe the compliance to SOP and aseptic behavior and indentify the deficiencies, if found any.</p><p>13. To Excute the Aseptic Core Monitoring during batch processing activity.</p><p>14. To participate in Media fill activities and ensure the review and compliance of the activity as per the Batch Records and protocols.</p><p>15. Preparation of PQR data for the product manufactured in year on rolling basis.</p><p>16. Collection and evaluation of Batch process parameters(CPP), Quality attributes from batch record and analytical record.</p><p>17. To review the Non Viable trends of Production Area.</p><p>18. To Perform any other works as and when assigned by HOD.</p>