Job Overview
- Manage/ perform quality operation/activities for Santen Korea to ensure its compliance with applicable local regulatory and Santen requirements for importation, local testing, repackaging, storage and distribution of Santen products.
- Provide support to maintain a fit for purpose local QMS as per applicable local regulatory authority and Santen’s global requirements to support country quality operation/activities.
- Perform quality activities and manage quality issues for Santen Korea/ CMO to support the continuous supply of Santen products in compliance to applicable local regulatory authority and Santen’s global/release requirements. Quality activities include performing maintenance of quality agreement, change control, KPI monitoring, quality complaints management, PMF update, SOP updates and periodic review of QA SOPs, training, self-inspection and audits, deviation/CAPA, risk assessment, preparing Annual Product Quality Review etc.
- Responsible for management of the contracted laboratories and ensure that method transfers are completed and compliant to applicable established and registered product specifications and requirements.
- Provide support to ensure all relevant quality input/support to business projects, new product introduction, product launches (including Analytical Method Transfer and DTP creation) and product variation are provided timely.
- Support management and execution of external/internal audit program for Santen Korea as per applicable local regulatory and Santen global requirements.
- Participate in ad-hoc activities as requested.
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