Home / Editorial Board / Lai Gek Yan
Contributor
Lai Gek Yan
QA Executive · Quality Systems & Regulatory Documentation Specialist
Lai Gek Yan is a Malaysia-based QA executive at Dr Orizi (M) Sdn. Bhd. 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 & highlights
- Role
- QA Executive · Quality Systems & Regulatory Documentation Specialist
- Based in
- Malaysia
- Education
- Bachelor of Engineering, Bioprocess Engineering — Universiti Malaysia Perlis
- Experience
- 6+ years in cosmetics and regulated manufacturing; QA Executive at Dr Orizi (M) Sdn. Bhd. — QMS documentation, audit preparation (internal, customer and SMETA), CAPA coordination and regulatory submissions
- Areas of expertise
- Quality Assurance
- Quality Management Systems
- Regulatory Documentation
- GMP Compliance
- ISO 13485 & ISO 22716
- Audit Readiness
- CAPA & Document Control
- Cosmetics Manufacturing
Verify & contact
- linkedin.com/in/lai-gek-yan-87462940a
These are Lai Gek Yan’s own profiles. Editorial queries and corrections: [email protected].
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.
Editorial role: Contributing writer.
Full method: How we research · Editorial Policy · Corrections Policy
Disclosure
This blog is published by ORIZI Group, a Malaysian OEM/ODM manufacturer. Our contributors write about the industry they work in — practical explanation from first-hand manufacturing experience.
Lai Gek Yan works as a QA executive in the cosmetics and regulated manufacturing industry at Dr Orizi (M) Sdn. Bhd., an ORIZI Group company — the publisher of this site.
Articles by Lai Gek Yan
Every article Lai Gek Yan has written or fact-checked for ORIZI Group is listed on their author archive.