Vertical : QA & QC

Skill

  • More than 7 years’ experience in Quality Assurance and Quality Control.
  • Knowledge in PPAP, APQP, SPC, FMEA, MSA ,8D report, 5WHY etc.
  • Prepare and submit 8D report and analysis report to customer.
  • Control and improvement measurement inspection method.
  • Reduce cycle time of inspection method and design new jig for support inspection method.
  • Verify new process before 4M change approved and submit data to customer.

Education

  • Bachelor’s Degree of Engineer, Major: Industrial Engineer

Skill

  • 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.
  • Certified both internal and external audit.
  • Good English communication skills. 

Education

  • Bachelor’s Degree in Science, Major Microbiology

Skill

  • Experienced in Quality System is more than 15 years and about 10+ years in medical and pharmaceutical
  • She is certified Internal Auditor
  • Experienced and knowledge in FDA’s inspection and registration.
  • Good skills and knowledge in ISO 13485, ISO 14971, GMP and GDP, DMR, and Process Validation IQOQPQ
  • GMP Plus Requirement and Interpretation
  • Effective Sampling Plan
  • Positive Thinking Development for Successfulness
  • Lean manufacturing system concept and application workshop
  • Risk Assessment to ISO 14971
  • ISO/IEC 17025
  • Hygienic Design in Food Industry

Education

  • Master’s Degree, Major in Science - Food Sanitation
  • Bachelor’s Degree, Major in Science - Agricultural Industry


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