Title:  Specialist Quality Assurance

QA Specialist role

The QA Specialist/Senior Specialist (3–8 years) will support end-to-end quality assurance activities for imported pharmaceutical products, ensuring full compliance with MFDS regulations and global quality standards. This role contributes to MAH quality responsibilities, oversees GMP/GDP activities, and collaborates with global partners, CMOs, distributors, and testing laboratories.

RESPONSIBILITY

ROLE & RESPONSIBILITY related to QA

• Safety report management including Individual Case Safety Report (ICSR) Submission

• 1. Collects, processes and forwards Safety Information to Global Case Process according to the relevant global SOPs, Local SOPs, and applicable agreements.
  2. Performs ICSR submissions to the local Health Authorities (HA) as per applicable local regulations, SOPs and agreements.
  3. Timely report all the safety reporting (PV reporting on IIT/PMS, SUSAR,

Quality System & Compliance

1. Operate and enhance the Quality Management System (QMS) in compliance with MFDS, KGMP Annex 4 (Importer GMP), GDP, and relevant ICH/PIC/S guidelines.
2. Manage deviations, CAPA, change controls, complaints, risk assessments, and product quality investigations.
3. Support internal/external audits and regulatory inspections; prepare necessary documentation and corrective actions.
4. Maintain and revise SOPs, work instructions, and training materials.

Import QA & Product Release

1. Perform GMP/GDP documentation review and batch release activities for imported products.
2. Review CoA, batch records, shipping documents, stability data, temperature excursion assessments, and QC test results.
3. Liaise with global QA, RA, manufacturing sites, and logistics teams regarding quality issues and compliance requirements.

Vendor & Warehouse Oversight

1. Oversee external warehouses, 3PL/4PL service providers, and contract laboratories to ensure GDP compliance.
2. Conduct periodic audits, qualification, and performance monitoring of vendors.
3. Ensure proper storage, handling, transportation, and temperature control across the supply chain.

Change Control & Documentation

1. Evaluate change controls related to manufacturing processes, packaging components, specifications, suppliers, and quality procedures.
2. Support lifecycle management activities, including MA transfer, new product launch, serialization, and QC testing changes.
3. Ensure timely reporting and escalation of product quality issues to internal and global stakeholders.

Cross-Functional Collaboration

1. Collaborate with PV for safety–quality linkage assessments and defect investigations.
2. Work with RA on variation submissions, renewals, and compliance updates from the QA perspective.
3. Participate in corporate projects such as warehouse consolidation, system implementation, and QMS transformation.

4. QUALIFICATION

• Bachelor’s degree or higher in Pharmacy, Life Science, Chemistry, Biotechnology, or related discipline.
• 3–8 years of experience in pharmaceutical QA (importer/MAH, manufacturer, or distributor).
• Strong understanding of MFDS regulations, GMP/GDP, and ICH guidelines.
• Hands-on experience with QMS processes (deviation, CAPA, change control, complaints, risk management).
• Strong verbal and written communication skills in Korean and English.
• Ability to interact effectively with global counterparts and external partners.

Preferred

• Experience in QA for imported products under MAH responsibility.
• Knowledge of QC testing, serialization, stability monitoring, and logistics oversight.
• Experience conducting or supporting internal/external audits.
• Familiarity with e-QMS/EDMS systems.