Ensure the required compliance to relevant internal standards, local and international quality and regulatory guidelines applicable to Good Manufacturing Practice for clinical trials supply chain activities and drive vital improvements.
Provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters.
Handle internal and external audits, and follow-up on resulting observations and opportunities for improvement.
Perform quality activities required by the Quality Management System.
Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business.
Responsible for quality reviews of process performance, product quality and of the Pharmaceutical Quality System and supporting continual improvement.
Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.
Perform ad-hoc duties as requested by line management.
Qualifications
Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies.
Ability to work independently under pressure and handle multiple tasks.
Good interpersonal skills.
Meticulous attention to detail.
Good organizational, written, and verbal communication skills in English and Korean.
Minimum Requirements Bachelor's degree in life science or related Medical/Pharmacy/Quality Assurance & Regulatory affair or higher.
Experience Previous working knowledge in the Pharmaceutical/Medical/Healthcare settings in the field of Quality Assurance and Regulatory affairs preferred.
