Job Description
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
2. Training Management
Develop and deliver regulatory / quality training programs for employees
3. 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 I...