$900,000 Per Year
$2,000,000 Per Year
Manages long-term and accelerated stability programs per ICH Q1A-F guidelines. Develops stability protocols for new products and post-approval changes. Reviews and approves stability data and prepares stability summary reports. Manages stability chambers, walk-in rooms, and ensures temperature monitoring. Coordinates with QC for stability testing and analytical method assignments. Prepares shelf life justification and regulatory submissions for stability data. Manages annual stability program and ensures no overdue samples. Investigates stability failures and prepares root cause analysis reports. Coordinates with regulatory affairs for submission of stability data changes. Prepares stability section of annual product quality reviews. Manages stability master plan and stability trending analysis. Supports regulatory inspections with stability documentation and data. Stays updated with ICH Q1 guidelines, regulatory guidance, and stability science.