QA Specialist or Manager/¿Ü±¹°èÁ¦¾àȸ»ç¿Ü±¹°è±Û·Î¹úÁ¦¾àȸ»ç¿¡¼ (Sr.) QA Specialist ȤÀº QA Manager¸¦ ã½À´Ï´Ù.
±Ù¹«Áö´Â °æ±â ¾È»ê½ÃÀÔ´Ï´Ù.PRIMARY OBJECTIVE:To ensure QA compliance to be in line with local pharmaceutical QA regulations as well asglobal QA policies and guidelinesCORE JOB RESPONSIBILITIES:- A Pharmacist to be in line with local QA regulations (as KGSP & ÀǾàÇ°¼öÀÔ°ü¸®ÀÚ) - 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
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´ã´çÀÚ : (ÁÖ)¸¶ÀϽºÅæ¼Ä¡ ¿øÇö¼÷»ó¹«(www.mstone.co.kr)¿¬¶ôó : 02-2050-0299, 010-8911-5018À̸ÞÀÏ : hs@mstone.co.krÁö¿ø½Ã Á¦Ãâ¼·ù : ±¹¿µ¹®À̷¼, ÀÚ±â¼Ò°³¼°¨»çµå¸®°í, ±Ã±ÝÇϽŠ»çÇ×ÀÌ ÀÖÀ¸½Ã¸é ¾ðÁ¦¶óµµ ¿¬¶ôÁֽñ⠹ٶø´Ï´Ù.
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