Operational QA

Reporting to QA Lead

Job Purpose

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

The position holder is responsible to:

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

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

Contribute to the continuous improvement of Quality Management System.

Key Responsibilities

Product Release for pharmaceuticals

Approve release of pharmaceutical products, which include but not limited to review of receipt documentation, temperature records, in-market test result and repacking.

Responsible to work with 3rd party logistics service providers, such as warehouse, 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 work’s CAPAs are identified, 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 / Technical Terms of Supply with Manufacturing Sites and Licensee

Act as LOC point of contact for Quality Agreement / TTS for the identified products.

Coordinate the review and approve Quality Agreement / Technical Terms of Supply with manufacturing supply sites.

Redressing

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

Review and Approve for redressing documents

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

Audit / Regulatory Inspection

Support GMP audit and regulatory inspection within LOCQ 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.

Requirements

• Bachelor’s degree in science (pharmacy preferrable)

• Pharmacist license required (Fresh Pharmacist is also OK)

• At least 2 years of experience in QA pharmaceutical industry is preferred.

• Experience in the management/use of quality system/product release is preferred.

• Operational experience, knowledge and application of cGMP/GDP and local regulation in artwork, secondary redressing, warehousing and distribution is preferred.

• 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

• English proficiency (written and spoken)

• Native level of Korean

*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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