QC/QA Senior Staff

Responsibilities

• Oversee registration and certification processes with the Thai FDA.
• Manage the entire process of obtaining ISO13485 and HALAL certificates, from application to acquisition.
• Lead ISO-related activities, including implementation, training, audits, and updates.
• Maintain and manage documentation related to ISO, HALAL, test results, QA/QC, and other relevant documents
• Handle GMP (GDP) activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Supervise team internally.

Qualifications

• Bachelor's degree or higher in a relevant field.
• Intermediate to business-level English proficiency.
• 4-5 years of QA/QC experience.
• Expertise in ISO, QMS, Thai FDA regulations, and pharmaceutical consulting.
• Experience in company setup and managing ISO or certification applications is a plus.
• Strong project management skills.
• Willingness to relocate to the factory in AIES, Lat Krabang.