• Manage finished product release & third party lab.
• Fulfill quality activities (Deviation, audit, training and documents etc.) in accordance to all cGMP requirements and Korea regulations
• Develop and maintain Korea quality assurance system and SOPs in lined with HQ quality management system
• Manage the Korean package artworks and Korean drug barcode in compliant with local standards
• Oversee re-labeling activities – Prepare Korean specific labeling in accordance with MFDS requirement
• Participate in compliance audits as an auditor/auditee and respond to audit observations
• Ensure the compliance of regulatory requirement as MFDS registered responsible person of Medical device quality
• Support local warehouse management with SCM according to the local requirement.
• Provide quality input as GMP compliance matter expert
• Maintain the license for drug and medical devices selling and importation
• Complete QA/RA duties as assigned
• Management of regulatory database of electronic system
경력 및 자격요건
• Relevant qualification in bachelor’s degree (bio or chemistry related background preferred)
• 3~5 years experience in QA in medical device or pharmaceutical company
• Proficient in MS Office, including Word, Excel and Power Point
• Effective communication and interpersonal skills
• Good verbal and writing English skill is preferred
• Work systematically according to regulations
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
