Stability Statistician-Analytical ChemistryPosted: November 14, 2009
Provides statistical analysis for chemical data. Supports the global pharmaceutical, vision care, and surgical stability programs; providing analysis and trending of stability data for regulatory filings and technical assessments of stability specifications. Run regression analysis and use various statistical methodologies to provide insight to shelf-life/expiry dates, temperature statbility, etc. Job Duties: - Acquire and develop appropriate statistical software tools to interface with a laboratory LIMS system, provide suitable statistical trending of data, and generate reports and tables in formats suited for regulatory submission - Interact with product development teams to support stability analysis for new product development and regulatory submissions. -Respond to regulatory agency questions. - Interact with internal and external contacts at a variety of levels, including Regulatory Affairs, Analytical Research & Development, Formulations Development, and Process Development. - Establish expiry dating for Clinical Trial Material across all business units. Please refer to job code 754664 when responding to this ad.
|
