QA Specialist

Job Purpose

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. The position holder is responsible in ensuring product launch and product supply to the market are safe, regulatory compliance and timely manner.

In addition, this position is responsible for providing the contribution to the compliance and continuous improvement of the Quality Management System.

The persion is required to build and maintain effective working in achieving GSK business objectives in Innovation, Performance, Trust and Culture.

Key Responsibilities

Batch Release Review for Rx products

• Review the batch release of Rx products, which include but not limited to review of receipt documentation, incoming inspection record, temperature records, in-market test result, site CoA, and repacking records

• Responsible to work with 3rd party logistics service providers, such as warehouse, and LOC relevant functions in ensuring GSK and regulatory requirements are met

• Approve the pharma products release as Qualifed Person (QP), including Vx as back-up person.

• Process owner of Product Release process.

KPS (Korean Product Standard) & PPR(Periodic Product Review)

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

• Prepare and document KPS and PPR for the pharmaceutical products

• Approve KPS and PPR as QP

• Process owner of KPS

Repacking & Repacking operation

• Review and coordinates RRF

• Review and Approve for repacking instruction and repacking batch record

Deviation and Third Party Incident(TPI) Management

• Lead and support timely completion of deviation and/or Third Party Incident(TPI) investigation, and ensure root cause and CAPAs are identified.

• Support LOC Quality Operations Manager with issue handling

Corrective and Preventative Actions (CAPA)

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

Change Management

• Assess change control records and ensure all implementation actions are identified

Product Incident/ Recall support

• Support any local product quality incident/ recall that might affect the product in terms of quality, safety and efficacy

Quality Agreement with Manufacturing Sites and Licensee

• Review Quality Agreement with manufacturing supply sites

Audit / Regulatory Inspection

• Support GxP audit and regulatory inspection within LOCQ and GSK warehouse or distribution sites managed by LOC

• Support MFDS communication as QP

Internal audit

• Process owner of Internal Audit process

• Prepare and manage Audit Universe and Audit schedule.

• Ensure internal audit is conducted in a risk based approach.

• Be involved in internal audit program

• Act as an auditor during self-inspection or independent business monitoring (IBM)

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

• Coordination and Communication with warehouse staff (ZPK)

• Paticipate to quality and SOPs training session according to the individual training plan

• Provide proposals and advice in improving the quality system

Recall report to MFDS

• Report recall case to MFDS system as per the local regulation.

• Communicate a reporting case with regional PRS team

Back up person for incoming inspection

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

• Check the latest artwork code, version and authorization change date

• Check the temperature record of transportation

• Make sure the serial number is displayed correctly

Back up person for Product complaint

• Log the complaint and manages the complaints for the responsible products

• Communicate with the customer to have information which GSK site requests

• Prepare official customer response and communicate with the customer (if required)

• Perform local investigation (if required)

Requirements

• Pharmacist, Mandated by local regulation to certify product release

• At least 3 years of working experience in pharmaceutical industry.

• Experience in the management/use of quality system. Operational experience, knowledge and application of cGMP/GDP and local regulation in artwork, secondary repacking, warehousing and distribution.

• Experience on QA and warehouse

• 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)

• Excellent 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 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.

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