Tan Ka Hern Email & Phone Number

Singapore

• Refer to ‘Project’ section for status of deployment.
• Deliver projects in GMP Consulting, Risk & Compliance and Project Quality Management.
• Provide expert consultancy in the areas of Manufacturing Operations Management (MES,MOM), GMP Compliance, Process and Equipment Validation (CQV), Computer System Validation (GxP, CSV).
• Risk Management, Change Controls and Quality Management for Pharmaceutical Manufacturing Operations Projects.

Malaysia

• Upstream Production Biotechnologist specializing in GLP- and cGMP-regulated lab-scale (5L) cell expansion and industrial-scale (5kL to 50kL) cell culture fermentation. As team lead, I am capable of conducting and.
• Shopfloor Management - Perform housekeeping and plant inspection to uphold compliance and audit readiness; ensure all equipment are subjected to timely calibration and preventive maintenance.
• Fermentation Expertise - Knowledge in monitoring cell culture growth (OD and WCW check), fermentation parameter control, metabolite analysis, harvesting and cell separation.
• Process Troubleshooting - Good understanding of block diagram, action expression details, phase transition and handshake of logic between recipes in Delta V DCS.
• Deviation Investigation - Participate in investigation for events such as parameter out-of-range and batch failure to identify potential root causes.
• Documentation Competency - Perform gap analysis for SOP, checklists and BMR; preparation of quality documents such as Risk Assessment, Impact Assessment, Change Control and CAPA report.