Chen Yee Goh Email & Phone Number

Osaka, Japan

Experienced engineer specializing in pharmaceutical industry consulting, delivering project-based solutions tailored to client needs. Skilled in providing technical support and guidance for remediation and improvement to ensure compliance with industry standards.Experienced project types in PQE:Evaluation of Inspection Readiness; Support for Inspection Preparation;Quality System and Compliance; Documentation Review and Improvement;Third Party Audit related to GMP, ISO9001, Supplier questionnaire audit, Man-in-plant (MIP);Contamination Control Strategy (CCS), Cross-contamination Risk Assessment;Nitrosamine Risk Assessment; Cleaning Validation Risk Assessment;Validation Master Plan preparation; Process Performance Qualification / Process Validation;Translation of technical documentation.

Japan

Conduct feasibility study for new possible production run;Ensure smooth technical transfer process, starting from laboratory trial to full-scale commercialized run;Documentation preparation and review (e.g. production batch record sheets, SOP, process change request, reports) in compliance with protocols and regulations;Assisting in process validation for change implementation;Involve in troubleshooting in the event of production problem;Continuous process evaluation to ensure both efficiency and quality remain optimized and stable;To collect and review laboratory and production process data for process optimization, process improvement and cost down implementation;Utilized language and communication skills to facilitate overseas teleconferences, customer visits, plant tours, and other international engagements.

Malaysia

Handling customer complaints reported, provide technical support and seeing problem through to resolution;Ensure customer satisfaction by providing extensive technical support and continuous product improvement to meet customer's needs;Act as a solution provide to customer, by ensuring the product quality from in-house production development phase to commercial production run phase at customer site (local & overseas);Preparation and regular revision of product documentation (e.g. Technical Data Sheet) to reflect in-house production capability.

Shah Alam, Selangor, Malaysia

Assisted in analyzing machine downtime for improvement;Calculation of raw material wastage along the transfer pipeline;Draft preparation of working instruction and blank forms for new raw material transfer system.

Master'S Degree Of Business Engineering, Business Engineering

Activities and Societies: Participant of Career Development Course for Foreign Students from Asia; International Teaching Assistant.

Chemical Engineering, Chemical Engineering

Activities and Societies: Participant of Chem-E-car Competition, University Science Malaysia; First Runner Up in Plant Design Team.