QA Specialist (Product Release, Replacement of Maternity leave)

Job Purpose

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

The position holder is responsible to:

• Authorize Vaccine 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

Vaccine Product Release Review for pharmaceuticals

• Release 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, 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.

• Support LOC Quality Lead

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.

Repacking

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

• Review and Approve for repacking batch record about repacked vaccine products before repacking operation

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 Vaccines and Biological products

Local release testing support

• Preparation about reference standard for Vaccine

• Payment about local release testing fee on a monthly basis

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

• At least 2 years’ experience in QA pharmaceutical industry or licensed pharmacist of Korea

• Experience in the management/use of quality system

• 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)

• Operational experience, knowledge and application of cGMP/GDP

*LI-GSK

Skills

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.