Chee Wei Lim Email & Phone Number

Singapore

Singapore

- Assist site management to provide oversight on quality system execution on the manufacturing, warehouse, engineering and QC operations for Biologics and API production.- Key roles include incoming raw material release, review of completed paper/electronic batch record and release of API/BDS, leading and closure of investigations/exception reports, conducting periodic quality walkthrough in various operation areas, performing of quality tag-outs.- One of the key quality representative… Show more - Assist site management to provide oversight on quality system execution on the manufacturing, warehouse, engineering and QC operations for Biologics and API production.- Key roles include incoming raw material release, review of completed paper/electronic batch record and release of API/BDS, leading and closure of investigations/exception reports, conducting periodic quality walkthrough in various operation areas, performing of quality tag-outs.- One of the key quality representative for start-up preparations for Biologics plant including, providing user input and review/approval of MES (Manufacturing execution system) related documents and eBR (electronic batch records), review and approval of operations (Bio, IT, engineering etc) SOPs, generation and implementation of quality procedures (such as GMP readiness, batch release), review and approval of BOM and SAP recipes, and participating in risk assessments (as required). Show less

Tuas, Singapore

- Lead and supervise a team of 12 - 18 technicians in non-aseptic team to contribute to the production and delivery of quality product while ensuring safety, GMP compliance and operational efficiency- Core member of Facility Expansion Project since 2013 to provide user requirements and input in the conceptual design of new facility and process scale up via process modeling, data collection and analysis & discussion with local and global stakeholders. - Project management: Autoclave… Show more - Lead and supervise a team of 12 - 18 technicians in non-aseptic team to contribute to the production and delivery of quality product while ensuring safety, GMP compliance and operational efficiency- Core member of Facility Expansion Project since 2013 to provide user requirements and input in the conceptual design of new facility and process scale up via process modeling, data collection and analysis & discussion with local and global stakeholders. - Project management: Autoclave improvement project and commercial campaign readiness for new product Show less

Tuas, Singapore

- QA oversight for VS Coupling manufacturing activities: on-the-floor GMP compliance, tag-out management, deviation investigations and CAPA implementation, Change control, QA review and approval of documentations- Led in complex deviations (media simulation failure investigation, particle in final product container)- Intermediate batch release to restricted status, review of products for suitability for forward processing

Tuas, Singapore

- Performed Quality investigation for Commerical Products: Led significant quality investigation in support of Lot Release within defined Standard Lead times, Conducted Root Cause Analysis sessions with Subject Matter Experts and evaluation of corrective actions, supported FDA/EMA Pre-Approval Inspection in strategy and preparation sessions- Assignment and closure of CAPA- Supported discrepancy management training of MQA and QC staff in support of Quality re-organization- Summarized… Show more - Performed Quality investigation for Commerical Products: Led significant quality investigation in support of Lot Release within defined Standard Lead times, Conducted Root Cause Analysis sessions with Subject Matter Experts and evaluation of corrective actions, supported FDA/EMA Pre-Approval Inspection in strategy and preparation sessions- Assignment and closure of CAPA- Supported discrepancy management training of MQA and QC staff in support of Quality re-organization- Summarized and compiled data for investigation for Annual Product Review- Supported New Hire Training Program as a Quality trainer (for GMP and GDP) during the on-boarding of new employees at the site - Trained as Risk Assessment Facilitator (Process Hazards Analysis and Failure Modes and Effects Analysis)- Supported QA change control process as change controller- Trained as Document Approver Show less

Tuas, Singapore

Deviation Investigation Writer II (CHO operations)- Performed deviation investigation and report writing - Evaluation of Product impact assessment, root cause determination and implementation of appropriate CAPAs- Close collaboration with colleagues of different levels and departments- Set-up meetings as necessary for significant deviations that require multiple areas of investigation or having potential impact to product.Biotechnologist II, Upstream (CHO… Show more Deviation Investigation Writer II (CHO operations)- Performed deviation investigation and report writing - Evaluation of Product impact assessment, root cause determination and implementation of appropriate CAPAs- Close collaboration with colleagues of different levels and departments- Set-up meetings as necessary for significant deviations that require multiple areas of investigation or having potential impact to product.Biotechnologist II, Upstream (CHO operations)- Supported Avastin Engineering runs and training of new team members for cGMP production. Show less

Portsmouth, Us

- Gained deep insight to cGMP and compliance in the biopharmaceutical industry.- Qualified to perform all general upstream operations including Inoculum Operations (Aseptic Technique, Operation of C02 Mixer, Gassing of cultures, Inoculum grow-up using E Flask/Roller Bottles/wave units, etc), Monitoring and operation of 100L, 1kL, 4kL, 20kLbioreactors & Harvest skid, CIP/SIP/Helium testing and other tank operations (Inoculation, Fill, Transfer, etc), Support instruments (Pumps, Scales, Tube… Show more - Gained deep insight to cGMP and compliance in the biopharmaceutical industry.- Qualified to perform all general upstream operations including Inoculum Operations (Aseptic Technique, Operation of C02 Mixer, Gassing of cultures, Inoculum grow-up using E Flask/Roller Bottles/wave units, etc), Monitoring and operation of 100L, 1kL, 4kL, 20kLbioreactors & Harvest skid, CIP/SIP/Helium testing and other tank operations (Inoculation, Fill, Transfer, etc), Support instruments (Pumps, Scales, Tube Welders, Sealers, Integrity Tester, etc), Sampling and Basic laboratory tasks (Nova, Osmometer, cell count, pH meter, centrifuge, Vicell, etc), Routine sanitization tasks to maintain facility standards, First Level Review of Manufacturing Batch Records.- Qualified trainer for CIP/SIP/Sampling Operations.- Acquired solid operating knowledge of Delta V/PI Historian/LIMS System.- Attained strong understanding of critical process and operational parameters.- Assisted in deviation/contamination investigations and process improvements.- Actively contributed to Operational Excellence (5S) efforts.- Supported Project Validation (Involved in the final stages of Fermentation Suite Expansion Project including drafting and effective execution of validation ( IQ/OQ/PQ) protocol for bioreactors and associated systems. Familiar with the use of Kaye Validator and Biological Indicators for SIP Validation, and Generation of PI, LIMS, Discrepancy and Summary reports. Show less

Shanghai, China

- Assumed responsibilities in Engineering, Production, Scheduling and Materials Planning and Purchasing aspects. Gained insight into the operational and management concerns of the labor-intensive manufacturing environment.- Assisted Manager in process audit, optimization, and quality management. - Led in the upgrading of Pretreatment line and Waste water treatment Plant - Process troubleshooting, product analysis, material sourcing and formulation of new SOP.- Pioneered debut… Show more - Assumed responsibilities in Engineering, Production, Scheduling and Materials Planning and Purchasing aspects. Gained insight into the operational and management concerns of the labor-intensive manufacturing environment.- Assisted Manager in process audit, optimization, and quality management. - Led in the upgrading of Pretreatment line and Waste water treatment Plant - Process troubleshooting, product analysis, material sourcing and formulation of new SOP.- Pioneered debut project of Plastics Pad printing - Administered implementation, training and monitoring of work processes. Liaised with vendor on equipment and material purchase. Prepared First Article report. Coordinated with purchasing and sales department on material supply and product shipment. - Mastered Production Planning and Scheduling using SAP system, mentored new planner and compiled bilingual training manual. - Conducted training lessons for office and Quality Assurance Team on Basic English and Computer Skills. Show less