Healthcare Quality & Regulatory Compliance, Senior Specialist

Seoul, KoreaFull-timeSeniorPosted Nov 3, 2026

Ensure compliance with Korean healthcare / pharmaceutical regulations ( Eg KGSP)
Approve incoming / released/returned products through specification and visual checks
Maintain and update key quality documents ( Quality Manual, SOP, WI)
Conduct internal audits and oversee environmental hygiene
Interpret regulatory standards and ensure process compliance

Training Management Develop and deliver regulatory / quality training programs for employees
Quality Issue Management

Report and manage suspected counterfeit or adulterated products
Investigate and improve QMS issues ( Change Control, Deviation, CAPA)
Record and monitor quality issues to prevent recurrence Job Requirements / qualifications
Knowledge and practical experience related to the medicines Act
Experience with ISO integrated management systems
Internal audit and quality system enhancement experience
Experience in delivery / transportation service quality management
Practical understanding of KGSP and regulatory standards
QMS operation and quality documentation management skills
Audit and problem solving capabilities ( including CAPA /SOP optimisation )
Training design and delivery skills
Strong cross functional communication and collaboration
Fluent or intermediate level in Korean and English as the role required to communicate with overseas counter part and reporting to overseas manager
Possess valid local Pharmacist License Working hours: Mon to Fri 9am-6pm

Description copied from Flintex's careers page. Read the full posting before you apply.

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