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About this position

The Senior Quality System and Compliance Officer is responsible for maintaining the Quality Management System (QMS) and ensuring compliance with company procedures, relevant standards, and regulations.

Responsibilities

• Maintain QMS and document control in order to comply with requirements of company procedures, relevant standards and regulations.
• Review and register controlled documents before make them valid according to procedure and requirements.
• Preparation and submission of the dossier to health authority (Thai FDA) according to regulatory requirement for manufacturing license renewal and other affairs as assigned by supervisor.
• Prepare the dossier and process to be legalized as requested in order to supporting product export purpose.
• Handling CAPA system.
• Coaching staff to understand document control requirement for issuing, review and valid according to procedure and requirements.

Requirements

• Bachelor degree in Science or related field.
• Minimum 3 years’ experience in Quality Management System (QMS).
• Knowledge of ISO 9001/ ISO 13485.
• Able to lead and experience in Internal & External Audit.
• Computer literate.
• Good command of English.

Benefits