1.    Responsible for co-ordination of stability study related activities with IPQA, QC and F& D.

2.    To ensure compliance of GMP, GDP & SOPs in stability area.

3.    To ensure charging of stability samples as per stability protocol.

4.    To ensure timely withdrawal of stability samples as per schedule.

5.    To maintain the stability chambers and review temperature and RH data of stability chambers.

6.    To review list of samples for destruction.

7.    To prepare and review stability protocols.

8.    To ensure timely compilation stability summary reports and approved of stability summary reports.

9.    To maintain track of stability studies and prepare & review monthly stability sample testing schedule.

10. Responsible for approval of LIMS stability protocol / summary.

11. To perform Alarm verification as per Schedule and time synchronization of stability chambers.

12. To ensure timely transfer of stability samples to out-side labs.

13. Responsible for submission of document to Regulatory affairs department as per requirement.

14. To perform activities like review, tracking, task closing and TCD extension of CRFs related to stability studies.

15. Knowledge of SAP & LIMS transaction.

16. Knowledge of QMS activity (i.e. OOS, OOT deviation & change control).

17.  To ensure compliance of GMP, GDP & SOPs in stability area.