Regulatory Affairs Specialist (Food)
About this position
Responsibilities
• Draft quality assurance policies and procedures.
• Interpret and implement quality assurance standards and procedures.
• Evaluate adequacy of quality assurance standards.
• Devise sampling procedures and directions for recording and reporting quality data.
• Review the implementation and efficiency of quality and inspection systems.
• Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality.
• Document internal audits and other quality assurance activities.
• Investigate customer complaints and non-conformance issues.
• Collect and compile statistical quality data.
• Analyze data to identify areas for improvement in the quality system.
• Develop, recommend and monitor corrective and preventive actions.
• Prepare reports to communicate outcomes of quality activities.
• Identify training needs and organize training interventions to meet quality standards.
• Coordinate and support on-site audits conducted by external providers.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Coordinate and facilitate to internal and external organization (government, authorities and customers).
• Monitor FDA rules and other related laws that have impact on company’s products and company's operation.
• Register and renew company's license and certification.
Requirements
• Bachelor Degree in Bachelor’s degree or higher in Microbiological, Food Science, Food Technology or an equivalent qualification.
• 5 years’ experience and up in consumer products in the field of Regulatory Affairs.
• Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement.
• Experience in Quality Assurance and management level (HACCP, GMP, ISO) preferably in food industry.
• Quality inspection, auditing and testing experience.
• Experience with implementation of corrective action programs.
• Product or industry-specific experience.
• Strong computer skills including Microsoft Office, QA applications and databases knowledge of tools, concepts and methodologies of QA.
• Solid experience in effective usage of data analysis tools and statistical analysis.
• Knowledge of relevant regulatory requirements.
• Strong communication, organizational and presentation skills with excellent command of Thai and English language, both oral and written.