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[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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