[모집개요]
회사 : 외국계제약회사
포지션 : (Sr.) QA Specialist
회사위치 : 경기 안산시
[모집부문]
직위 : 과차장급
담당업무 : 외국계글로벌제약회사에서 (Sr.) QA Specialist 혹은 QA Manager를 찾습니다.
근무지는 경기 안산시입니다.


PRIMARY OBJECTIVE:
To ensure QA compliance to be in line with local pharmaceutical QA regulations as well as global QA policies and guidelines


CORE JOB RESPONSIBILITIES:
- A Pharmacist to be in line with local QA regulations
(as KGSP & 의약품수입관리자)
- To be an interface for local TPL (Third Party Lab) management to release
a product in a timely manner
(including Regular audit on TPL to ensure QA compliance,
TPL service agreement management)
- Successful management of KFDA inspection & global audit for
business continuity
- Communication with Corporate QA to comply with Corporate
QA policies and guidelines
- Label development and over labeling management to comply with
local regulation
- Monitor and disseminate information on the regulation changes related to
QA and implement the changes as stipulated on the regulations
- QA documentation and its maintenance such as product master file,
CAPA and SOPs
경력요건 : EDUCATION/QUALIFICATIONS/EXPERIENCE:
- Pharmacist
- Minimum 3 years of QA experience or QA relevant experience in
Pharmaceutical companies
- Good knowledge of local regulations on KGMP/KGSP/QA
- Good communication skills in English preferred
- Good computer skills
연령 : .
학력 : 정규대졸
어학 : 영어
컴퓨터 : .
연봉 : .
특이사항 : 약사
[담당자/문의처]
담당자 : 원현숙상무
전화 : 02-2050-0299
제출서류 : 국영문 이력서, 자기소개서
전자우편 : hs@mstone.co.kr