- 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
- 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
Job description provided by Flintex.
View the original posting