About the Role
Description
Key Responsibilities
This position is responsible for facilitating the initiation of commercial stability studies, tracking the enrollment of stability batches, assembling, analyzing and reporting of stability data.
The responsibilities include authoring stability initiation documents and other related documents including the Master Stability Protocols, Study Specific Protocols, CMO Stability protocols and Batch enrollment forms.
Responsible for creation and tracking of the stability annual requirements, and year end requirement check
Responsible for batch identification as per annual program
Responsible for LIMS study creation and data management.
Responsible for stability data entry, reporting and trending into reports (e.g. Annual Product Quality Reports, Annual Reports, Annual Product Stability Reviews, and other reports).
Assembles, revi...
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