Lai Gek Yan
QA Executive · Quality Systems & Regulatory Documentation Specialist
Malaysia
About
Lai Gek Yan is a Malaysia-based QA executive at ORIZI Group with more than six years of experience in cosmetics and regulated manufacturing. Her work covers quality management system documentation, SOP development and document control, compliance work aligned with ISO 22716 (cosmetic GMP) and ISO 13485 (medical devices), audit preparation for internal, customer and SMETA audits, CAPA coordination, and regulatory documentation including Medical Device Authority establishment-licensing support and export documentation. She writes about manufacturing quality, compliance and product development.
Credentials
- Role
- QA Executive · Quality Systems & Regulatory Documentation Specialist
- Education
- Bachelor of Engineering, Bioprocess Engineering — Universiti Malaysia Perlis
- Experience
- 6+ years in cosmetics and regulated manufacturing; QA Executive at ORIZI Group — QMS documentation, audit preparation (internal, customer and SMETA), CAPA coordination and regulatory submissions
Writes about
- Quality Assurance
- Quality Management Systems
- Regulatory Documentation
- GMP Compliance
- ISO 13485 & ISO 22716
- Audit Readiness
- CAPA & Document Control
- Cosmetics Manufacturing
Editorial role
Contributing writer.
Research approach
Gek Yan reviews regulatory guidance, applicable standards, technical documentation, official company information and credible industry sources. Information is cross-checked against practical manufacturing and quality-system considerations wherever reasonably possible.
Disclosure
Lai Gek Yan works as a QA executive in the cosmetics and regulated manufacturing industry at ORIZI Group, the publisher of this site.