AQA - Chemist To Officer

Role & responsibilities

1. To review batch release documents for raw material/packing material /in process/intermediate /finished product/stability like test protocol / report, electronic data, chromatograms, audit trail, spectra, etc.

2. To execute audit trails and review the activity to verify the integrity of data.

3. To review electronic data back up and verification of restoration study, computer system validation, etc.

4. To review calibration/qualification/PM schedule/installation documents for instruments in Quality Control department.

5. To review analyst qualification and training related documents of quality control department.

6. To review documents related to working standard / reference standard / impurity standard / reference material / GC standard.

7. To review stability schedule and related analytical data.

8. To review holding time stability study data & related analytical data.

9. To review quality management system related activity for Quality Control (Change Control, Deviation, Quality Complaints, QRM).

10. To review investigation and ensure closure of laboratory incidents.

11. To review investigation and ensure closure of OOS/OOT/OOC in Quality Control department.

12. To review all the trends related to quality control activity

13. To review of documents related to microbiological activity like, environmental monitoring, water testing, finished product testing, validation-based testing, instrument calibration and validation activities, etc.

14. To take QC rounds and support in maintaining GLP, logbooks review, etc.

15. To review SOPs, specification and method of analysis, test reports / protocols / documents related to QC.

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