概要

• 給与

  60,000 THB ~ 80,000 THB

• 業界

  Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)

• 仕事内容

  Key Responsibilities
  
  
  1. Regulatory Affairs
  - Ensure compliance with Thai FDA, MOPH, ASEAN Cosmetic Directive, and TISI (if applicable).
  - Handle product registrations, notifications, and license renewals.
  - Review formulations, labeling, and claims for regulatory compliance.
  - Track and implement regulatory updates in Thailand and SEA.
  
  2. Quality Assurance
  - Maintain and improve Quality Management Systems (QMS).
  - Ensure compliance with GMP and relevant ISO standards.
  - Approve raw materials, packaging, finished products, and vendor documents.
  - Conduct internal and supplier audits; support external audits.
  Manage deviations, complaints, and CAPA processes.
  
  3. Supplier & Manufacturing Oversight
  - Qualify and manage third-party manufacturers and suppliers.
  - Ensure manufacturing meets quality and regulatory requirements.
  - Support product scale-up and commercialization activities.
  
  4. Documentation & Reporting
  - Maintain SOPs, specifications, COAs, and regulatory records.
  - Prepare reports for internal teams and regulatory authorities.
  - Support inspections and audits by Thai FDA and other bodies.