Analytical Operations Specialist (1Y 8M, Replacement of maternity leave)

This position ensures pharmaceutical products registration in Korea market is timely and compliant with GSK and MFDS regulatory requirements in terms of Specification and Test methods.

• Coordinates and supports analytical test method set up/change associated with global/local changes including New Product Introduction and Existing Products.

• Third Party Laboratory Management for Release testing and Analytical Method Transfer

• Reagent management for Analytical Method Transfer

• National Inspection technical support in terms of Specification and Test Methods

This position is responsible for providing the contribution to the compliance and continuous improvement of the Quality Management System, especially for lab management system. Develops and improves LOC quality systems in line with the strategies and policies. Responsible to implement and monitor LOC Quality strategy.

1. Lab management

• Coordinate Analytical Method Transfer between manufacturing site and 3rd party laboratory

• Review transfer analytical data, documents and reports (protocol, report)

• Facilitate logistics activities related to testing set-up by third party laboratory, such as managing importation of reagent and products (document preparation for custom clearance, register to register in Korea Chemicals Management Association (KCMA) etc.)

• Work with Procurement to create or revise 3rd party laboratory contracts

• Review test methods document for license registration and change

• Organize and manage periodic review

1. Deviation and Out of specification (OOS)  and TPI

• Lead and support timely completion of investigation for OOS and Lab deviations and ensure root cause and CAPAs are identified.

• Review and approve(if necessary) Third Party Issue

1. Change control

• Liaise and coordinate change control process with 3rd party laboratory in ensuring the quality requirements are addressed.

1. CAPA

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

1. Audit/ Regulatory inspection

• Perform MM/IBM if required

• Support GMP audit, MFDS inspection, ESA audit and any other A&A audits on request

1. Third Party Laboratory Management including incident management

• KPI/Performance review

• Contract management

• Support global team for Quality Agreement management and Audit

1. Reagent management

• Oversee the compliance aspect of reagent importation to Korea for local testing

• Ensure to maintain an up-to-date reagent list requirement

• Monitoring of material inventory in MFDS and 3rd party labs

1. Analytical Method Transfer management

• Overall planning and management of new products and life-cycle-management AMTs

• Korea SPOC

1. Quality Regulatory Intelligence (QRI) and Pharmacopoeia Intelligence / Quality Alert / Quality Bulletin

• Assess and implement any changes in QRIs, Pharmacopoeia, Quality Alert and Quality Bulletin impacting product supply and communicate these change to LOC and GMS

1. Risk Management

• Identify the risk and, lead or support timely completion of Mitigation actions on Risk.

1. QMS

• SOP owners for assigned QMS topics

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

• Provide proposals and advise to improve the quality system

1. Team Management

• Create a work environment that encourage open conversation and collaboration.

• Bachelor’s degree or equivalent / Science (Biology, Biochemistry, Microbiology, Biotechnology or Applied Chemistry)

• 3 years in QA/QC, QC experience is highly preferred.

• Knowledge in quality and regulatory requirements (GSK QMS, Regulation, Policy)

• Self-starter with continuous improvement mindset

• Strong in implementation with business mindset

• Enjoy challenge and problem solving

• Strong Team player, able to work collaboratively with colleagues and stakeholders (Teamwork)

• English proficiency (written and spoken)

• Excellent interpersonal and communication skills

*LI-GSK