The Quality Affairs Specialist will oversee quality assurance functions in Thailand and other assigned Southeast Asian (SEA) countries, including:
- Developing and implementing quality management system manuals, guidelines, and procedures that comply with the Thai FDA's Good Importing and Sales Practice (GISP) Notification.
- Ensuring compliance with GISP regulations.
- Establishing document control processes.
- Conducting internal training on quality awareness and documentation.
- Supporting logistics suppliers and sales teams in aligning with internal and external quality standards.
- Collaborating with regulatory affairs and vigilance teams on product complaints and adverse events.
- Assisting supply chain teams with critical quality activities such as stock blocking and traceability.
Qualifications and Experience
- Bachelor's degree in a science-related field.
- Minimum of three years experience in quality roles, preferably in the medical device, pharmaceutical, or food industries.
- Familiarity with Thai FDA regulations and ISO standards (ISO9001, ISO13485).
- Certified quality system auditor.
- Strong analytical, communication, and planning skills.
- Fluent in English, with the ability to work both independently and collaboratively.
Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.
