York Chow Wai

1. Experienced in driving manufacturing optimization, tech. transfer and validation in highly regulated cGMP environments.

2. Skilled in leading and supporting cross-functional teams to deliver manufacturing excellence.

3. Understanding of international standards (ICH, FDA, HSA, EMA)

4. Supported value stream as lead for Cleaning, Scheduler, Purified Water, Sustainability role.

4. Lead manufacturing processes to enhance yield, reduce cycle times, and minimize cost per unit.

5. Execute of cleaning validation protocols to meet cGMP and regulatory requirement.

6. Lead RCA investigation using structured OB methodology and implement effective CAPAs.

7. Support audits as SME.

8. Mentor junior engineers and provide training on best practices in manufacturing environment and compliance.

• Process/cleaning validation based on Statistical data (i.e Cpk and Cpnk), MQ assessment, process related QO, PQ and PPQ. Change Control lead, CPV lead for existing processes.
• Site equipment, yield related optimization and improvement. Material assessment impact assessor.
• Process deviation investigator lead, complete with 6M, 5W, Ishikawa analysis, RCA.
• Drafting URS and perform FAT and SAT testing of the function and recipe. PID tuning.
• SME of process validation, cleaning validation, process deviation, investigation during authority inspection (FDA, HSA, PMDA, ANSM)
• EHS related protocol, report, RA, HAZOP, writing/support.
• Experience in Batch processes, Heinkel inverting centrifuge and other centrifuges, different type of dryers, reactors.
• Mentoring Juniors

• Area owner for technical development laboratory. Laboratory safety.
• Experience in laboratory seed preparation, contamination control, and plant fermentation process.
• Ensure the stability of manufacturing processes via DCS trend and laboratory monitoring data.
• Change control documents related to all manufacturing change.
• Responsible for technical transfer in or out from Singapore site, include laboratory use test, cleaning studies, propose scaled up parameters practically based on equipment precision.
• Submit user spec. requirement and plant mod. requirement. Participate in all manufacturing related RA, HAZOP, and EHS assessment.
• Participate in process deviation, investigation, impact assessment, RCA, and CAPA except QC related matter.
• Process validation, cleaning development/ validation (limit calculation, lab. analysis procedure validation, recovery test, cleaning method validation).
• Involved in process MB determination/ update, process yield estimation, estimate raw mat. quantity, calculation of cost/unit consumption and feedback all related impact.
• Experience in FDA PAI inspection.
• Familiar with ICH and FDA guideline and requirement.