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.
Pharmacovigilance
• Handling of drug safety related information and report it to HQ and local authority -Serious adverse events from studies and spontaneous adverse
events occurred from products
• Report monthly reconciliation with MIS & Quality complaints
• Provide PV training to relevant stakeholders
• Fulfill the required tasks according to local & global procedure and
regulations .
• Management of local PV SOPs
• Ensure a scientific and regulatory intelligence related to
Pharmacovigilance.
• Learn HQ PV system & procedures and assess/ implement it to local
SOPs & procedures.
• To be registered to MFDS as PV responsible pharmacist.
• Fulfill MFDS PV inspection
경력 및 자격요건
•Pharmacist required
•More than 3 years experience in pharmaceutical company (QA and PV experience
preferred)
•Proficient in MS Office, including Word, Excel and PowerPoint
•Good verbal and writing English skill is P「efe「red
•Work systematically according to reglations
•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
