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
Refer code: 884246. Sun Pharmaceutical Industries Ltd - The previous day - 2024-01-22 11:23
Address
Tandalja - R&D