Regulatory Affairs and Quality Specialistรหัส:75651

60,000 THB ~ 80,000 THBติดรถไฟฟ้า MRTประมาณ 14 ชั่วโมง ที่ผ่านมา

ภาพรวม

  • รายได้ต่อเดือน

    60,000 THB ~ 80,000 THB

  • ประเภทธุรกิจ

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

  • รายละเอียด

    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.

คุณสมบัติ

  • คุณสมบัติ

    【Must】

    - Bachelor’s or Master’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or related field.
    - 5–8 years of experience in QA and/or Regulatory (cosmetics or supplements).
    - Experience working with Thai FDA, MOPH, and ASEAN regulations.
    - Experience with third-party manufacturers.

    【Advantage】
    - Experience with US/EU regulations is a plus.

  • ความสามารถทางภาษาอังกฤษ

    Level 3 - Business Level

  • ความสามารถทางภาษา (อื่นๆ)

    None

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