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.

- 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

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

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