Qa Executive(AQA)

Analytical Assurance

1. To review analytical specifications, standard and general test procedures, test data sheet of raw material, packing material, finished product, stability and micro analysis.

2. To review the data submitted by QC for its completeness.

3. To ensure management of working/ reference/ impurity standard and column management.

4. To ensure contemporaneous documentation.

5. To check raw data /audit trail / software (as applicable) at a given frequency to ensure regulatory guidance compliance.

6. Responsible for finish product, stability, Raw material, packaging materials, micro results and in process sample batch release in LIMS.

7. To review of stability protocols in coordination with stability group and review the stability report

8. To review predictive stability analysis on data generated for stability study

9. Review of analytical method transfer and method validation documents.

10. To coordinate with CQA/ PTC department for implementation related to the official monographs/ General chapters/ corporate quality policy.

11. Reviews of documents i.e. risk assessment, change control, deviation and routine documents of testing area associated to the function.

12. To ensure retrieval of QC data and support for its presentation during audit.

13. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.

14. Responsible for release of Raw materials, Packaging material, Stability Study, in process, Microanalysis and finished products.

15. Responsible for Review of Raw materials, Packaging material, Stability Study, in process, Microanalysis and finished products analytical report before release.

16. Responsible for Stability chambers management (Withdrawal/charging of stability samples, Monitoring of Stability chambers temperature and humidity, preventive maintenance of stability Chambers, Calibration of stability calibration). To charge and withdraw stability samples as per scheduler. To maintain and monitor storage conditions of stability chambers and to ensure recording of temperature & humidity of all stability chambers as per the defined frequency. To identify and report to QA for any excursions to the defined storage conditions of the stability chamber. Responsible for reconciliation of stability sample.

17. Responsible for Management of control samples of finished product, raw materials and packaging material.

18. Responsible for Review and release of Calibration before release of instrument for routine use.

19. Responsible for Review of analytical data for process validation and analytical data for market complaint.