Sr Spec, Quality Assurance

The Quality Assurance Specialist supports and maintains quality and regulatory compliance for pharmaceutical and medical device operations in Korea. Key duties include managing product release documentation, leading analytical method transfers, handling field actions and complaints, and ensuring timely post-market reporting to the Ministry of Food and Drug Safety. The role involves conducting gap analyses, maintaining local quality documents and licenses, and supporting internal and external audits in alignment with GMP and MFDS regulations.