Healthcare Quality & Regulatory Compliance, Senior Specialist

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 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

Requirements
Healthcare Quality & Regulatory Compliance, Senior Specialist