Tan Ka Hern

Experience

• 

  Biocon

  Oct 2018 - Feb 2023

  Manufacturing Engineer

  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 executing automated sterile production process operation, with expertise in QMS documentation under GDP guideline.• 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.• Inventory Management - Ensure process order and reservation of raw materials and consumables are created and closed in SAP.• Cross Functional Project Management - Participate in equipment IQ, PQ and RQ activities, analyze and compile generated data for preparation of report.• Process Improvement - Execute production campaigns in cooperation with R&D at improved process parameters to achieve enhanced product yield; proactively perform comparative process metrics analysis and highlight potential causes for difference in performance between equipment. • Process and Layout expertise - Ability to interpret Process Flow Diagram (PFD) and Piping & Instrumentation Diagram (P&ID) significant for supporting modification engineering works. Show less

• 

  NNIT

  May 2023 - now

  Pharmaceutical Consultant

  **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.