Description

Site Name: Seoul Yongsan Tower
Posted Date: Aug 20 2025

Job Purpose

This position ensures pharmaceutical products registration in Korea market is timely and compliant with GSK and MFDS regulatory requirements in terms of Specification and Test methods.

• Coordinates and supports analytical test method set up/change associated with global/local changes including New Product Introduction and Existing Products.
  
• Third Party Laboratory Management for Release testing and Analytical Method Transfer
  
• Reagent management for Analytical Method Transfer
  
• National Inspection technical support in terms of Specification and Test Methods
  

This position is responsible for providing the contribution to the compliance and continuous improvement of the Quality Management System, especially for lab management system.

• Develops and improves LOC quality systems in line with the strategies and policies.
  
• Responsible to implement and monitor LOC Quality strategy.
  

Key Responsibilities

1. Lab management

• Coordinate Analytical Method Transfer between manufacturing site and 3rd party laboratory
  
• Review transfer analytical data, documents and reports (protocol, report)
  
• Facilitate logistics activities related to testing set-up by third party laboratory, such as managing importation of reagent and products (document preparation for custom clearance, register to register in Korea Chemicals Management Association (KCMA) etc.)
  
• Work with Procurement to create or revise 3rd party laboratory contracts
  
• Review test methods document for license registration and change
  

2. Deviation and Out of specification (OOS)

• Lead and support timely completion of investigation for OOS and Lab deviations and ensure root cause and CAPAs are identified.
  

3. Change control

• Liaise and coordinate change control process with 3rd party laboratory in ensuring the quality requirements are addressed.
  

4. CAPA

• Ensure all related work's CAPAs are identified, implemented, monitored and closed out on time
  

5. Audit/ Regulatory inspection

• Perform MM/IBM if required
  
• Support GMP audit, MFDS inspection, ESA audit and any other A&A audits on request
  

6. Third Party Laboratory Management

• KPI/Performance review
  
• Contract management
  
• Support global team for Quality Agreement management and Audit
  

7. Reagent management

• Oversee the compliance aspect of reagent importation to Korea for local testing
  

• Maintain an up-to-date reagent list requirement
  
• Monitoring of material inventory in MFDS and 3rd party labs
  
• Work with supply chain to ensure proper contract and agreement are in place for customs agency
  

8. Quality Regulatory Intelligence (QRI) and Pharmacopoeia Intelligence / Quality Alert / Quality Bulletin

• Assess and implement any changes in QRIs, Pharmacopoeia, Quality Alert and Quality Bulletin impacting product supply and communicate these change to LOC and GMS
  

9. Risk Management

• Identify the risk and, lead or support timely completion of Mitigation actions on Risk.
  

10. QMS

• SOP owners for assigned QMS topics
  
• Participate to quality and SOPs training session according to the individual training plan
  
• Provide proposals and advise to improve the quality system
  

Requirements

• Bachelor's degree or equivalent / Science, Biology, Biochemistry, Microbiology, etc.
  
• Minimum 2 years QC and QA experience in pharmaceutical industry
  
• Knowledge in quality and regulatory requirements
  
• Self-starter with continuous improvement mindset
  
• Strong in implementation with business mindset
  
• Enjoy challenge and problem solving
  
• Good Team player, able to work collaboratively with colleagues and stakeholders (Teamwork)
  
• English proficiency (written and spoken)
  
• Good interpersonal and communication skills
  

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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