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

Incoming control of products at ZPK warehouse

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

• Conduct incoming inspection of Rx and Vx products.

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

• Check the temperature record of transportation

• Make sure the serial number is displayed correctly

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

Incoming control of repacking materials at ZPK warehouse

• Inspection of repacking material in comparison with approved artwork

• Check the printing quality and defect

• Review CoA provided from printing agency with acceptance criteria

Repacking & Repacking operation

• Ensure repacking operation procedures are complied with LSOP, PGSOP and LOC regulation as process owner

• Prepare the repacking instruction

• Conduct training of repacking process to ZPK and inspection of repacking activity

QC test request & sample management

• Owner of LOC sample management process

• Prepare test request form and deliver to ZPK for the dispatch

• Conduct Vx product sampling

• Manage QC test schedule

• Manage retention samples in accordance with LSOP, PGSOP, LOC regulation and local requirement

Product complaint

• Log the complaint and manages the complaints for Rx 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)

Deviation and Third Party Incident(TPI) Management

• Lead and support timely completion of deviation and/or 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

Return

• Ensure that the return procedure is in place and in use

• Check returned products with ZPK and KSC team.

Projects

• Participate and lead the projects to provide any supports to achieve LOC objective in a timely manner

Product Incident/ Recall support

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

Audit / Regulatory Inspection

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

Internal audit

• Be involved in internal audit program

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

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

Reagent management (back-up)

• Reagent Order

• Overall management of reagents, including maintenance of an up-to-date reagent master file, monitoring of material inventory 3rd party labs for in-market testing for products, monitoring transportation temperature, and approval of reagent usage.

Requirements

• 경기도 안성시 미양로 156 GSK warehouse 근무 가능자 (자차 운행/기본 근무지로 별도 유류비 및 교통비 지원 없음)

• Bachelor's degrees other than those related to science equivalent

• At least 1 years of working experience in pharmaceutical industry. 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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