Lay Choo Yau

Managed and supported regulatory inspection by US FDA, Russian MIT and HSA. Lead and support internal audit across different facilities. Oversee compliance in QC laboratories, emphasising on chromatographic review, SOP adherence and Data Integrity.

My involvement in this new set up are getting the lab ready (from project phase to routine lab), recruitment and analytical method transfer for drug substance of biologics. I am also the lead for 6s implementation in QC lab.

•I were required to lead a team of analysts in providing prompt analytical service to support production activities by reviewing of test data and test methods, involve in quality audits, performing annual product and stability review, investigation (ie. trouble-shooting, implement corrective and preventive actions) and documentation of non-compliance issues. I am familiar with LIMS, Empower and QTS system. • I was required to play an active role in analytical method development and validation for existing product due to production process change, involved in method transfer for new product introduced to Singapore site, writing of protocols, analytical reports, Change Control & SOPs, periodic review of compendia methods and equipments, provide training to colleagues, involve in quality audits, review of analytical report and data. • I am a member of specific Product Focus Team (PFT), where I played an active role in the brainstorming of the specific product process improvement, resolving and supporting plant issues.

Acting Quality Supervisor (Mar 2009 – Sept 2009) • I was required to lead a team of chemists and analysts in providing prompt analytical service to support production activities by reviewing of test data and test methods, qualification of vendors, involve in quality audits, performing annual product review, investigation (ie. trouble-shooting, implement corrective and preventive actions) and documentation of non-compliance issues. Quality Chemist (Jul 2002 – Oct 2009) • I was required to play an active role in analytical method validation / transfer / development using HPLC, GC, FTIR, etc, calibration of instruments, qualification of new instruments (ie. Liquid Chromatography Mass Spectroscopy), writing of protocols, analytical reports & SOPs, update of written SOPs, periodic review of compendia methods, provide training to colleagues, review of analytical report and data. Beside that, I was also required to perform ad-hoc samples investigation (using GC, GCMS, HPLC, LCMS, etc) from production and R&D. • I was actively involved in the method validation of various projects (ie. newly invented drugs still in clinical phase) from method review to method familiarization to writing of protocols and summary report to ensuring that all SOPs are up to date. I also had to interact closely with colleagues from various departments (ie. production, R&D and other laboratories) and the Analytical Team from the HQ via teleconference and emails, to resolve any queries and/or investigation. Cleaning Validation Chemist (Sep 2000 - Jun 2002) • My main responsibilities involve analysis of samples from the production department after cleaning to check for degradants from previous process to prevent cross-contamination. My job also requires me to perform shifts, to liaise with various production departments and to ensure all samplings are in compliance with cGMP requirement. My job requires me to have good working knowledge of cGMP and also to enhance teamwork and safety.