Regulatory
• Compile, submit and follow up on product registration/ product variation applications for responsible projects/ products according to the planned/ targeted timeline.
• Follow up amendments related to product variation to meet the regulatory compliance.
• Monitor routinely the regulatory environment and to implement in a timely manner or spread out to the responsible department if necessary.
• Strategic analysis and evaluation of regulatory environment change on drugs/medical devices
• Answer/ fulfill requests/ queries originating from local authorities (MFDS, MOHW, KPIS, and HIRA etc.)
Quality Assurance
• Manage quality processes including quality complaints, deviation, CAPA, change control, etc.
• Support quality activities of internal/ external audits, technical transfer, annual quality review, training, quality management review, etc.
• Quality documents management on drugs and medical devices as required by local regulation
• Manage import product (drug, device) quality standard documents
• Support in warehouse management, quality control testing, import batch control for product release
• Manage Korean package artworks and Korean drug barcode in compliant with local/global procedure and KR regulation.
경력 및 자격요건
• Pharmacist required
• Minimum 3 years experience in pharmaceutical company (QA experience preferred)
• Proficient in MS Office, including Word, Excel and PowerPoint
• Good verbal and writing English skill is preferred
• Work systematically according to regulations
• High responsibility on duties
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
