Experienced in Quality System, Quality Assurance, and RA with more than 10 years.
Experience in Medical Device product, Pharmaceutical and food producing as well.
Experienced in U.S.A. FDA’s inspection and audit by herself as internal auditor.
Experienced in the ISO 13485 quality system with the 21 CFR 820 QSR and Medical Device Directive (CE Mark), including documentation control, change control, design controls, complaint handling, non-conforming products, CAPA.
Ensure the Quality Management System (QMS) is effectively established, implemented, and maintained to follow ISO9001, GMP/HACCP and other relevant regulatory requirements in Thailand and all other applicable requirements.
Inspection methods/reviews compliance under quality management, Human and Resource development, Analyst and Coaching skill, Internal audit, Quality supplier development, GMP, HACCP, BRC, FSSC 22000, ISO 13485, ISO 9001, ISO 14001, OHSAS etc.