Regulatory Affairs and Quality Specialistรหัส:75651
60,000 THB ~ 80,000 THBติดรถไฟฟ้า MRTประมาณ 15 ชั่วโมง ที่ผ่านมาภาพรวม
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
ข้อมูลเพิ่มเติม
สวัสดิการ
- SSO
- Guaranteed Bonus
- Health and life insurance
- Dental treatment benefits (5,000 THB per year)
- Provident fund contribution: 5%
- Annual leave: 8–14 days
- Other benefitsเวลาทำงาน
09:00 ~ 18:00
วันหยุด
Sat-Sun, Public holiday
ประเภทงาน
กรุณาลงชื่อเข้าใช้