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Healthcare Quality & Regulatory Compliance, Senior Specialist

Seoul, KoreaFull-timePosted Oct 9, 2026

Job description

  1. Regulatory & Quality Compliance
  • 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
  1. Training Management Develop and deliver regulatory / quality training programs for employees
  2. 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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