Derek Quek Yeang
Quality Assurance Manager
Shah Alam, Selangor,10
Summary
Dynamic Quality Assurance Manager with extensive experience in quality control processes and team leadership within manufacturing environments. Expertise in leveraging data-driven methodologies to proactively prevent defects and ensure adherence to regulatory standards while fostering a culture of continuous improvement. Implement and execute successful quality assurance strategies, identifying deficiencies, and implementing effective solutions. Skilled in conducting vendor audits, performing thorough root cause analysis, and driving corrective and preventive actions (CAPA) to enhance operational efficiency.
Overview
18
18
years of professional experience
1
1
Certification
3
3
Languages
Work History
Quality Assurance Manager
Ansell Shah Alam
07.2021 - Current
- 1) Manage Quality Assurance Team, through Development and Performance Plan process, coaching and development, training, team building and empowerment.
- 2) Establish, monitor and continuously improve Quality Key Performance Indicators (KPI) which include Product Quality and Quality System indicators.
- 3) Manage product specifications and ensure products are released according to specifications
- 4) Manage NC (Non-Conformance) and CAPA (Corrective Action & Preventive Action) on critical product and system non conformances and drive for effective and timely closure.
- 5) Ensure Quality Management System is adequately and effectively established, implemented, maintained and continuously improved in accordance to international standards such as ISO 9001, other relevant standards, PPE regulations, and customer requirements.
- 6) Manage NC (Non-Conformance) and CAPA (Corrective Action & Preventive Action) on critical product and system non-conformances and drive for effective and timely closure.
- 7) Manage and improve customer complaints effectiveness through effective corrective and preventive action.
- 8) Manage and monitor supplier performance, initiate SCAR (Supplier Corrective Action Request) on critical supplier issues and ensure timely and effective closure.
- 9) Ensure product and process changes, product transfers are managed through Change Control Process with all changes adequately validated.
- 10) Work with R&D to ensure new products are adequately validated prior to commercialization.
- 11) Manage incoming, in-process and pre-shipment quality inspection, and laboratory testing
- 12) Appointed as Quality Management Representative (QMR) and report to plant management the effectiveness of QMS.
- 14) Manage internal and external audits.
- 15) Interface with customers and other external bodies in matters relating to quality.
- 16) Manage department budget.
Associate QA Manager
Nitritex (M) Sdn Bhd (Ansell)
12.2018 - 07.2021
- 1) Manage and supervise a team of quality assurance and laboratory on daily inspection (incoming, in-process and pre-shipment inspection), laboratory analysis (product performance), daily non-conformities.
- 2) Handling of customer complaints from various regions (APAC, EMEA and US). Conduct complaint investigation and issue of CAPA plan for continuing improvement.
- 3) As a management representative overseeing QMS system in the company, review and approval of change control, organize management review, monitor departmental KPI.
- 4) Establish yearly supplier audit schedule, conduct the audit at supplier manufacturing site, issue of audit report and follow up on the corrective actions.
- 5) Review quality agreement and quality assessment issued from customer, handling external audit from certificate body (SGS) and customer audit upon request from various regions.
- 6) Involve in new product development meeting to provide analytical and technical support to the team (marketing, production, purchasing and etc).
- 7) Lead / participate in Lean project. Set target, organize routine meeting, analyze root cause and set action plan.
- 8) Experience in cleanroom production, PPE and product sterility (sterility validation and dose mapping).
QA Executive
Nestle Manufacturing (M) Sdn Bhd
12.2012 - 12.2018
- 1) Supervise and train QA personnel to ensure accuracy and reliability of analytical work is achieved and maintained.
- 2) Involve and assist in pest control setup for Plant (Milk Powder and Culinary Sauce) and monitor the pest integration management
- 3) Review and monitor QMS and plant HACCP (Milk Powder and Culinary Sauce).
- 4) Experience in direct steam pasteurization, batch cooking pasteurization process, filling and packing in pouches, can and bottle. Ensuring product quality meeting micro result (TPC, EB, Yeast and Mould).
- 5) Conduct monthly KPI reporting, Business quality review and yearly management review.
- 6) Laise with supplier for incoming quality issue and monitor for corrective actions.
- 7) Troubleshoot in-process non-conformities and quality related consumer complaints to ensure continuous improvement on product quality are met.
- 8) Conduct yearly net weight review for complying with local and exporting regulatory requirement.
- 9) Monitor product Nutritional Value declaration to meet Malaysian Food Act and others country legislation.
- 10) Work with various functional teams (Production, Application and Engineering) and provide technical support (food safety and quality) on recipe / packaging change projects and processing line improvement.
- 11) Ensure Quality and Food Safety standards in the products are met by close monitoring of the processing and improvement of Good Manufacturing Practices (GMP) in factory.
- 12) Ensure that GMP, Food Safety and quality awareness are implemented, understood and practiced by all employees.
- 13) Certified lead auditor by SGS. Exprience in conducting internal audit and handling external audit (e.g ISO 22000, HACCP, SIRIM, MOH and JAKIM). Follow up audit gaps finding and closure.
QA Executive
Ngo Chew Hong Oils & Fats Sdn Bhd (Mewah Group)
01.2008 - 01.2012
- 1) Monitoring and testing quality of raw material (crude palm oil), end product of palm based oil from plant production, plant utilities and boiler / cooling tower water analysis.
- 2) Possess technical skill on analytical instrument such as Near-infra red spectrophotometer (NIR's), UV-Vis spectrophotometer, Karl Fischer titrator, and moisture detector.
- 3) Maintain and improve laboratory SOP to ensure department procedures and / or work instruction are being adhered to ISO 9001, ISO22000 and HACCP.
- 4) Monitor waste water treatment system to comply regulation and standard enforced by DOE.
- 5) Handling and dispose of laboratory chemical waste by segregate waste types and arrange transportation / waste collector for disposal.
- 6) Plan and organize laboratory work efficiently to achieve monthly KPI, including maintenance and calibration of laboratory equipments.
- 7) Monitoring in-process non-conformities and handling customer complaint through setting of correction and preventive action in SOP.
- 8) Manage and recruit laboratory assistant to ensure smooth running of daily department operations (routine testing task, documentation and report recording).
- 9) Conduct in house GMP and HACCP training to employee.
- 10) Appointed as document controller involve in the implementation, handling and continual improvement of ISO document.
- 11) Appointed as Food Safety Coordinator in the factory, involved in maintaining/ updating/review SOP related to food safety (ISO 22000 and HACCP) and organize for ISO external audit / surveillance audit. Assist QMR and IQA during external auditing.
Medical Technologist
Hospital Columbia Sdn Bhd
07.2008 - 10.2008
- Perform varies medical diagnostic test
- Routine housekeeping / daily maintenance on medical instruments
Education
Bachelor of BioTechnology - Biotechnology
Monash University
01.2008
Skills
MS Excel
Certification
Malaysian Driving License Class D
Timeline
Quality Assurance Manager
Ansell Shah Alam
07.2021 - Current
Associate QA Manager
Nitritex (M) Sdn Bhd (Ansell)
12.2018 - 07.2021
QA Executive
Nestle Manufacturing (M) Sdn Bhd
12.2012 - 12.2018
Medical Technologist
Hospital Columbia Sdn Bhd
07.2008 - 10.2008
QA Executive
Ngo Chew Hong Oils & Fats Sdn Bhd (Mewah Group)
01.2008 - 01.2012
Bachelor of BioTechnology - Biotechnology
Monash University