Work in Quality Control - Insulin; Analyst-senior Executive (3-5 Yrs) @ Biocon
Job Description
1. cGMP (Current Good Manufacturing Practice) and cGLP ( Current Good Laboratory Practice) regulations should be aware .
2. Production process control in coordination with production for receipt of stability samples.
3. In process samples inspection, testing and review.
4. Finished product, Stability product inspection and testing.
5. Product traceability- Reserve samples and stability samples.
6. Customer complaints relating to quality of the product.
7. Identification recording and evaluation of all Nonconforming products.
8. Corrective and preventive actions as and where applicable.
9. Maintenance and Calibration of Measuring and Testing Instrument belonging to the Quality Control laboratory in coordination with Maintenance Department.
10. Preparation, Review and maintenance of Quality Records.
11. Preparation and Review of product specifications and Analytical reports.
12. Analytical Method Validations and method transfers.
13. Through knowledge on Process validation and Cleaning validation procedures.
14. Updation of stability protocols and calibration records of all Laboratory Equipment/Instruments.
15. Handling of OOS, Deviations and Incidents
16. Qualification and requalification of Analytical instrument.
17. Coordinating with the cross functional teams to address regulatory queries.
18. Maintaining team co-ordination and functional relationship.
Click here to apply
Job Description
1. cGMP (Current Good Manufacturing Practice) and cGLP ( Current Good Laboratory Practice) regulations should be aware .
2. Production process control in coordination with production for receipt of stability samples.
3. In process samples inspection, testing and review.
4. Finished product, Stability product inspection and testing.
5. Product traceability- Reserve samples and stability samples.
6. Customer complaints relating to quality of the product.
7. Identification recording and evaluation of all Nonconforming products.
8. Corrective and preventive actions as and where applicable.
9. Maintenance and Calibration of Measuring and Testing Instrument belonging to the Quality Control laboratory in coordination with Maintenance Department.
10. Preparation, Review and maintenance of Quality Records.
11. Preparation and Review of product specifications and Analytical reports.
12. Analytical Method Validations and method transfers.
13. Through knowledge on Process validation and Cleaning validation procedures.
14. Updation of stability protocols and calibration records of all Laboratory Equipment/Instruments.
15. Handling of OOS, Deviations and Incidents
16. Qualification and requalification of Analytical instrument.
17. Coordinating with the cross functional teams to address regulatory queries.
18. Maintaining team co-ordination and functional relationship.
Click here to apply
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