Ernest Chua Email & Phone Number

Singapore

Singapore

• Sole Process Validation Lead in entire planning, executing and ensuring compliance in validation activities and technology transfer between SG, CN and US
• Site Computerised Systems Validation representative and technical expert for validation of SDLC on customised computerised systems software for testers
• Coordinate cross functional projects locally and internationally across CN, UK and US adhering to ISO9001/13485
• Contract Manufacturing Site Lead in manufacturing operations
• Primary subject matter expert in Trackwise deviations and change control records
• Technical expert in resolution, troubleshooting and analysis during day-to-day operations process issues (RCA, CAPA)

North West, Singapore

• Cross-functional validation with computer systems validation (eg. SoloVPE, UV-VIS, GC) according to GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good.
• Spearheaded multi-commissioning projects (IOPQ) related to big equipment (cold rooms/autoclaves) and small equipment (biowelders, sealers) in compliance with FDA standards
• Led validation activities through the entire Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, PV)
• Lead and maintain validation plans - Cross-departmental collaboration with multi-functions (engineering, automation, quality)Troubleshooting and data analysis of validation records (SAP, LIMS, PI)

Singapore

• Manufacturing Engineer
• Led and directed project enhancements in cell culture
• Resolved investigations pertaining to process deviations and change controls
• Troubleshooting process control systems and electronic batch management in commissioningQuality Specialist (Quality Assurance)
• Skilled in incoming raw materials and Bulk Drug Substance (BDS) quality release
• Implemented new and revision of Material/Master Specifications