Title:  Manager - 1

Job Summary

• As a Central Investigation Team member, primary role is statistical analysis of manufacturing data for the probable root cause and for other technical issues at site.
• Assessment for Dissolution similarity as part of submission requirements.
• Statistical support for query response.
• Other statistical analysis for content uniformity, probability of dissolution failures.

Area Of Responsibility

• Statistical analysis of process parameter and material attributes, to identify probable route cause.
• Shelf life extrapolation for filling and query requirements.
• Inverse extrapolation for release limits identification.
• Multivariate analysis for manufacturing investigations.
• Dissolution similarity by model dependent and independent methods.
• DoE for route cause investigation and confirmation as applicable
• Process capability assessment as needed.
• Training of CFT’s on Basic statistic and stability analysis
• Statistical support for justifying specification limits
• Content uniformity assessment as per need, based on ASTM E2709/E2810