[´ã´ç¾÷¹«] [OVERVIEW] QMS Implementation and maintenance for marketed products (Drug, General Cosmetics, Medical devices) in accordance with all applicable Korean regulations and internal Regional Quality policies. This position has main responsibilities in post-market management including local batch release in market for healthcare products registered under ZPT KR and Clients.
[ROLES AND RESPONSIBILITIES] - Qualified Person in Quality, registered pharmacist to MFDS - QMS (Quality Management System) improvement and simplification for ZPTx using tools of Deviation, CAPA, RCA, Risk management on issues occurred during daily working and Oversight local QMS established to ensure compliant ZPTx operations to meet both regulatory and customers¡¯ expectations. This includes harmonizing the quality standards and simplifying processes whiles driving both compliance and efficiency - Manage Batch release for the subject products (Drug, General Cosmetics, Medical Devices and/or Foods) which are registered under ZPTx and/or Clients in accordance with all applicable Korean regulations - Quality governance and Risk management including DMS (Document Management System) and ISO9001;2015 certification and maintenance. Own and implement Regional Quality system and processes, if applicable - Manage training relevant to Quality matters in a timely manner as per requirement - Oversight of quality performance for Local 3rd party contracted La. for local QC testing and standard materials for Drug in line with Batch release and relevant Tech transfer from manufacturing sites, if applicable - Collaborate with other Quality teams in ZP Korea and Regional ZPTx to promote sharing and learning and to align quality policies as one ZP - Conduct Internal and manage external audit/inspection and due diligence by competent authorities and clients - Partner with Supply Chain and ensure significant 3rd party related risks are appropriately escalated and mitigated in a consistent manner.
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