LEE YEAN WOAY
Director, Manufacturing
Bayan Lepas
Summary
A broad experience in both the medical device and pharmaceutical industries in overseeing manufacturing, process engineering, technical maintenance, operational excellence, quality control (QC), and validation. My ability to lead cross-functional teams and foster collaborative environments in achieving strategic goals. By effectively managing the team, I have driven significant improvements in operational efficiency, which resulted in remarkable cost savings and enhanced product quality, demonstrating that a strong leadership presence can yield tangible results.
Overview
23
23
years of professional experience
4
4
years of post-secondary education
Work History
Director, Manufacturing
Ambu Sdn Bhd
Penang, Bayan Lepas, 07
10.2020 - Current
- Develop and provide leadership to 9 departments: production, process engineering, technical, validation, quality control, facility management, and manufacturing operation
- Plan and direct the team to achieve objectives for quality, on-time delivery, inventory management, safety, and lean manufacturing
- Improve the profitability of products through cost improvements via productivity enhancement and waste improvement initiatives
- Drive operational excellence through maintaining and continuously improving efficiency
- Strategy plans for process improvement implementation to improve quality, maximize output, and minimize costs
- Initiate plans and processes that minimize manufacturing costs through the effective use of manpower, equipment, materials, and capital
- Create a healthy workplace to ensure employee engagement and development
- Plan and set an operational budget and monitor whether operational expenses are within budget
- Continually improve the safety record by addressing both physical safety issues and employee safety attitudes
- Maintain and improve 5S in all areas
- Driving cost reduction in COGS FY2122: 10.4 million FY2223: 5.1 million
- Driving cost saving in inventory stock, MUV & BC saving FY2021: 7.5 million FY2122: 12.4 million FY2223: 10.1 million
- Waste Reduction Achievement: FY2021: 1.72% FY2122: 1.63% FY2223: 1.30%
- NCR Reduction Achievement: FY2021: 457 FY2122: 367 (-19.7%) FY2223: 231 (-37%)
- Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
- Improved project efficiency with strategic planning, resource allocation, and time management practices.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
- Managed budgets effectively to ensure optimal use of resources while maintaining financial stability.
- Facilitated cross-functional collaboration for improved decision-making processes within the organization.
- Increased company revenue by streamlining processes and implementing cost-saving measures.
- Optimized inventory management to minimize costs and ensure product availability.
QC Manager cum Release Officer
Ambu Sdn Bhd
08.2010 - 09.2020
- Lead the whole quality control group inclusive engineer, executive, technicians and inspectors
- Managing all the quality control activities including incoming, in-process and outgoing
- Securing the Ambu A/S owned medical device products are manufactured according to the approved manufacturing specifications and Ambu Quality Management System requirements and to perform the final release of the Medical Device products
- Drive quality meeting for continuous improvement of product quality
- Weekly meeting with production and engineering on weekly quality issues
- Lead the lean management for the entire quality control department
- Develop, implement and monitor effectiveness of training program for quality control department
- Setup and validated (IQ, OQ) the test instrument for quality control laboratory
- Develop and validated (IQ, OQ) the software for quality control database
- Ensure department conformance and compliance to regulatory system (ISO 13485, FDA 21 CFR Part 820)
- Overseeing the department readiness for regulatory inspection
- Prepare and attend to the regulatory & customer audits (FDA inspection, UL audit)
- Involved in in-house auditing
- Involved in product transfer projects
- Involved in new product development projects
QA CHEMIST
Dynapharm (M) Sdn. Bhd.
11.2005 - 06.2010
- Lead the validation team (QA, QC, production & maintenance)
- Oversee the validation activities in the organization
- Review and approve validation plans and reports
- Provides technical and validation support for pharmaceutical facility, utility (HVAC system, purified water, compressed air & exhaust system), equipment, process, cleaning and tests method
- Participate in qualification of 100K cleanroom for OTC and Antibiotic manufacturing plant
- Setup and validated the cleaning process for pharmaceutical
- Prepare and attend to the regulatory audits (Drug Control Authority (DCA) inspection)
- Preform cGMP auditing
QA CHEMIST
Winwa Medical Sdn. Bhd.
08.2002 - 10.2005
- Designing experiments for Process Validation study and made recommendations for continuous improvement
- Generate, write and review QA department documents including procedures for production, calibration, product development and validation (protocol)
- Provide cGMP training to QA, QC and production personnel on procedure and process flow in accordance to the written procedure
- In-process controls and quality inspection of routine production to ensure compliance to the define procedure
- Calibration and reconciliation system control
- Environmental monitoring
Education
Certificate of Quality Engineering -
ARGI CONSULTANT SDN. B.H.D.
04.2001 - 08.2005
B.S(Hon) - Biochemistry
UNIVERSITY PUTRA MALAYSIA
STPM - undefined
S.M.J (K) JIT SIN
SPM - undefined
S.M.J (K) JIT SIN
PMR - undefined
S.M.J (K) JIT SIN
Skills
Operations management
Waste reduction
Cross-functional coordination
Continuous improvement
Goal achievement
Training
- Industrial Sterilization of Medical Devices – Sterilization Technologies & Associated Laboratory Testing
- ISO 13485 Process Based Internal Auditing
- Understanding of FDA 21 CFR Part 820
- Measurement System Analysis
- Acceptance Sampling Method
- Basic of Qualification & Validation
- Statistical Process Control
- Train the Trainer
- 7 Habits of Highly Successful Supervisor/Manager
- Value Stream Mapping
- Test Method Validation
- 8D Problem Solving
Accomplishments
- Production - Consistently met production and schedule levels.
- Produced finished parts at a rate of [Number] pieces per hour.
Timeline
Director, Manufacturing
Ambu Sdn Bhd
10.2020 - Current
QC Manager cum Release Officer
Ambu Sdn Bhd
08.2010 - 09.2020
QA CHEMIST
Dynapharm (M) Sdn. Bhd.
11.2005 - 06.2010
QA CHEMIST
Winwa Medical Sdn. Bhd.
08.2002 - 10.2005
Certificate of Quality Engineering -
ARGI CONSULTANT SDN. B.H.D.
04.2001 - 08.2005
B.S(Hon) - Biochemistry
UNIVERSITY PUTRA MALAYSIA
STPM - undefined
S.M.J (K) JIT SIN
SPM - undefined
S.M.J (K) JIT SIN
PMR - undefined
S.M.J (K) JIT SIN
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