Job Overview
- Management of overall quality operations for Santen in Korea to ensure its compliance with applicable local regulatory authority and Santen’s global requirements for importation, local testing, repackaging, storage and distribution of Santen products.
- Responsible as the Quality Management Representative Role for Santen in Korea and ensure the local QA operation/activities and the development, implementation and maintenance of a systematic, effective and efficient local Quality Management System (QMS) as per applicable local regulatory authority and Santen’s global requirements.
- Perform quality activities and resolve quality issues for Santen in Korea to support the continuous supply of Santen products in these countries in compliance to applicable local regulatory authority and Santen’s global/release requirements. Act as responsible pharmacist/importing manager if required.
- Responsible to ensure all vendors including suppliers/service providers used by Santen in Korea is compliant with all corporate/regional and regulatory cGMP/cGDP guidelines and SOPs.
- Maintain a quality compliance program for all vendors including an effective change management system.
- Management all relevant regulatory inspections or certification audits in Korea (GDP/GDPMD by regulators or certification body) to ensure successful maintenance / renewal of license and certification.
- Responsible to ensure Santen products produced by CMOs in Korea/Asia is compliant to applicable established and registered product specifications and requirements.
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