취업정보실

외국계 글로벌 제약회사-Quality controller(RA + QC position)

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익명
작성일
2008-04-11
조회
588
외국계 글로벌 제약사에서 Regulatory Affairs와 Quality control 업무 담당자를 찾고 계십니다.

약사 자격증 소지하거나 약학대학교 졸업하신 분을 선호하십니다.

<자격요건>
-RA + QC position이며, location은 서울 Regulatory Affairs에 두고, Report는 dual입니다.
-Gender 무관
-약사자격증 선호(Holding the Pharmacist license will be preferred)
-2 ~5 years experience in the pharmaceutical or related industry in Regulatory Affairs or Regulatory Compliance, Quality Assurance
-영어 능통(본사 보고)
-Broad scientific knowledge to allow understanding of chemistry/pharmacy, preclinical and clinical data and issues
-컴퓨터 활용능력 우수자

<업무내용>
-Responsible for ensuring compliance of activities in accordance with registered information and quality assurance issues within the Affiliate focused on compliance with current Country regulations and Company standards and policies focused on GXP- (e.g. GMP, GDP etc) related issues
-Develop and implement local “standard operating procedures” (SOPs) in accordance with current laws, Company standards / policies and business needs. Further maintain SOP process regarding periodical reviews etc.
-Assure training of all relevant people regarding effective quality standards e.g. SOPs, Company standards etc.
-Assure compliance to corporate quality standards e.g. Delivery of cold chain products
-Assist crises management teams in a case of recall.
-Assure audit activities in collaboration with the audit team and supporting departments in terms of audit preparation.
-Maintain commitment-tracking database.
-Assist in annual product quality reviews.

<지원처>
-담당자: 유도현 과장
-문의 전화: 02-6293-0025
-서류 접수: youlon@kornell.co.kr또는 master@kornell.co.kr (국, 영문 이력서)