Over twenty five years of pharmaceutical experience in the Quality Laboratories and Quality Services including 9 years of stability experience As a stability scientist main responsibility is to determine the appropriate shelf life/ expiry period and label storage statement for clinical and finished products such as drug products, cosmetics and medical devices. Oversees all aspects of the stability program from initiating stability study, preparing portions of regulatory submissions to commercial launch. Investigates quality issues, determines root cause, and initiates corrective action with the guidance of local and regulatory documents as well as other groups such as, Quality Assurance and New Product Development Group, when required.
|Laboratory Information Management System (LIMS), Non-Conformance Software (TrackWise), Documentum, Laboratory Automation System (LAS) Areas of expertise include: Knowledge of cGMP and GLP, GLIMS, Non-Conformance software (DEV, CAPA) Experience in HPLC, UV, IR, TLC, KF, Dissolution|
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