Description:

The QA Stability Specialist is responsible for implementing, leading and managing the iStability/LIMS software and entering the data in the software for all the ANDA batches and to perform the statistical evaluation of the data as and when required.

Essential Functions:

+ Create the studies for each product and each batch, enter the data and review and approve them in the software for each sample and evaluate them time to time.

+ Prepare, review and approve the stability protocols for all ANDA products. Manage and maintain the updates of the iStability/LIMS software and create and review the related SOP.

+ Prepare the stability reports, review the reports, and get them approved. Evaluate the data for trends and perform the statistical evaluation as and when required and escalate to management for any adverse trends.

+ Train the subordinates for iStability/LIMS software usage.

+ Identify extra samples in the sto...