JOB TITLE:

Lead Quality Engineer (Cell culture media)
DIVISION & DEPARTMENT: BPS / Quality


SUPERIOR’S TITLE: Quality Manager
WORK LOCATION: Songdo, (00000 Korea)


Job Summary:

Core project team leader responsible for the planning and execution of all quality assurance and quality control deliverables for bioprocess solution manufacturer until project handover. Governs functional, safety and regulatory compliance of products and processes for robust industrialization and launch. Manage advanced product quality planning in projects for new product introduction, engineering to order, product maintenance and capacity expansion.


Responsibilities:

Set up contaminzation control strategy for cell culture media production
Review and feedback to the utility system for sterile product production (WFI, sterilization, HVAC etc.) design, IQ, OQ, PQ and monitoring scheme
Set strategy for microbial test (Microbial limit, sterility, endotoxin and etc.) based on risk analysis of product, production environment, and process.
Participate actively to definition and review of qualification and validation protocols – CSV, Product, Process, Components/Sub-systems – ensure data driven validations and qualifications and monitor progress
Lead management of material, process and product quality attributes according to BPS quality standards – from functional analysis based on product URS, through design and process FMEAs (risk assessment), up to completion of process and product qualifications
Ensure full continuity between functional analysis, FMEAs, list of critical and significant material, product and process attributes, product specifications incl. drawings, control plan, work and inspection instructions in assigned project
Participate actively to or facilitate Design and Process FMEAs
Actively participate to definition and review of product specifications for raw materials and components
Specify, monitor manufacturing and approve gauges, checking and measurement equipment
Define inspection instructions for in-process control and for finished product incl. boundary samples and handbooks. Participate to operators/inspectors’ training plan definition
Plan, supervise, improve and approve all relevant Measurement System Analysis - for visual inspections and measurements
Where required, participate actively to definition of robust containment actions and CAPA definition to close gaps and secure launch

Interfaces:


Contruction and Engineering / Process Engineering / Supply Chain / Supplier Quality, Procurement, Production, Site Quality/ Regulatory Affairs, Product Compliance, FMEA Expert, Quality Efficiency Manager

Qualifications & Requirements:


Mminimum of a Bachelor’s degree in Microbiology, or life science related
Min. 5 years’ well-proven work experiences in microbiology QC/QA.
Experienced sterile and aseptic production related quality control
Familiar with biotechnology product and process and related GMP requirement
Project management experience: implement, master and track timing plan, key performance indicators and action plan.
English communication capability