Job Purpose

This position is to ensure that medicinal products release into Korea market are timely and compliant with GSK and MFDS regulatory requirement.

The position holder is responsible to:

• Authorize medicinal products are fit for purpose and suitable for distribution in Korea.

• Ensure GSK and local regulation compliance requirements for the medicinal products are met.

• Contribute to the continuous improvement of Quality Management System.

Key Responsibilities

Product Release for medicinals

•  Collection/Review of batch release documents for Medicinal products, which include but not limited to review of incoming inspection result, temperature records, in-market test result and redressing records, preparation of batch release documents, etc.

• Preparare and Review of Vaccine Summary Protocol in compliance with internal/external guideline

• Responsible to work with 3rd party logistics service providers, such as warehouse, local repacker in ensuring GSK and regulatory requirements are met.

Deviation and Incident Management

• Lead and support timely completion of deviation investigation and ensure root cause and CAPAs are identified.

Corrective and Preventative Actions (CAPA)

• Ensure all operational related CAPAs are established, implemented, monitored and closed out on time.

Change Management

• Lead and support change control process

• Liaise and coordinate change control process with LOC stakeholders in ensuring the quality requirements are addressed.

Quality Agreement with Manufacturing Sites and Licensee

• Act as LOC point of contact for Quality Agreement for the responsible products.

• Coordinate the review and approve Quality Agreement with manufacturing supply sites.

Redressing

• Ensure redressing procedures are complied with LSOP, PGSOP and LOC regulation

• Review and Approve for redressing batch record

KPS(Korean Product Standard) and APR(Annual Product Review)

• Ensure that the process for KPS and APR are in place and in use.

• Prepare and document KPS and APR for medicinal products

Local release testing support

• Preparation about reference standard for medicinal products

• Management payment about local release testing fee on a monthly basis

Audit / Regulatory Inspection

• Support GMP audit and regulatory inspection within LOC Quality and GSK warehouse or distribution sites managed by LOC

QMS

• Subject matter expert for assigned QMS topics

• Perform management monitoring or internal business topics for assigned QMS topics

• SOP owners for assigned QMS topics.

Customer Complaint

• Handling of coustomer complaints received for the responsible products in a timely manner

Requirements

• Bachelor’s degree in pharmacy(Preferred) or bio-science related

• At least 2 years’ experience in QA/QC medicinal industry

• Experience in the management/use of quality system

• Operational experience, knowledge and application of cGMP/GDP

• Self-starter with continuous improvement mindset

• Strong in implementation with business mindset

• Enjoy challenge and problem solving

• Strong Team player, able to interact and communicate well

• Korean/English proficiency (written and spoken)

*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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