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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
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