This position is responsible for providing Quality Assurance in enabling the GSK Quality requirements including all applicable local regulations, but not limited, are embedded and complied in its own working operations and executing areas.

• Ensuring product supply to the market are safe, regulatory compliance and timely manner.

• Providing the contribution to the compliance and continuous improvement of the Quality Management System.

• Building and maintainining effective working in achieving GSK business objectives in Innovation, Performance, Trust and Culture.

Key Responsibilities

Lab Operations

• 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

Document Control

• Manage LSOPs

• Responsible for compliance with internal and external guidance & regulation

• Develop and manage documents

Deviation and OOS

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

Change control

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

CAPA

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

Audit & Regulatory inspection

• Support GMP audit, MFDS inspection, etc. on request

Third Party Control

• 3rd party list & Contract management

• KPI review management

• Audit follow-up

Reagent management

• Maintain an up-to-date reagent list requirement

• Monitoring of material inventory in MFDS and 3rd party labs

Training System Management

• System and procedure management

• Assignment of trainings upon request and issue handling

Purchase Order Management

• Handling of purchase order in compliance with GSK policy

Requirements

• Bachelor’s degree or equivalent

• Major in Pharmacy, Biology, Biochemistry, Microbiology, Biotechnology, Pharmaceutical Engineering and Chemistry

• Prefers at minimum 1 years QC or QA experience in pharmaceutical industry Ensure level of understanding of compliance in GMP

• Knowledge in quality and regulatory requirements (GSK QMS, Regulation, Policy)

• Self-starter with continuous improvement mindset

• Strong in implementation with business mindset

• Enjoy challenge and problem solving

• Strong Team player, able to work collaboratively with colleagues and stakeholders (Teamwork)

• English proficiency (written and spoken)

• Excellent interpersonal and communication skills

*LI-GSK

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

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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