ÅëÇÕ°Ë»ö
ä¿ëÁ¤º¸
ÇìµåÇåÆÃ
ÀÎÀçÁ¤º¸
Ä¿¹Â´ÏƼ
Àαâ°Ë»ö¾î
:
¿µ¾÷
¸¶ÄÉÆÃ
ÀÓ»ó
¿¬±¸
Ç°Áú°ü¸®
ÀλçÃѹ«
»ý»êÁ÷
¾à»ç
ÀÎÇã°¡
°£È£»ç
- À̹ÌÁöºä -
(400x300)
¿Ü±¹°èÁ¦¾àȸ»ç-QM Specialist ä¿ë
http://www.reedglobal.co.kr
ȸ»ç¸í
(ÁÖ)·òµåÄÚ¸®¾Æ
´ëÇ¥ÀÚ
±è½Âȯ
»ç¿ø¼ö
¹ÌÀÔ·Â
ÀÚº»±Ý
¹ÌÀÔ·Â
»ç¾÷³»¿ë
ÇìµåÇåÆÃ,ÆÄ°ß,¾Æ¿ô¼Ò½Ì
¸ðÁýÁ÷Á¾
»ý»ê/Ç°Áú/°øºÎ/AS
£¾
Ç°Áú°ü¸®/Ç°Áúº¸Áõ
,
¿¬±¸/ÀÓ»ó/°³¹ß/Åë°è
£¾
¶óÀ̼¾½ºIn/Out
±Ù¹«Áö¿ª
¼¿ï
°³²±¸
ÀαÙÀüö
¼¿ï£¾2È£¼±£¾¿ª»ï 1¹ø Ãⱸ
´ã´ç¾÷¹«
QM, QA
¸ðÁýÀοø
2
¸í
±Ù¹«ÇüÅÂ
Á¤±ÔÁ÷
±Þ¿©»çÇ×
¸éÁ¢½Ã ÇùÀÇ
º¹¸®ÈÄ»ý
4´ëº¸Çè, ¿¬Â÷, ÁÖ5Àϱٹ«, ÅðÁ÷±Ý
ÀÚ°Ý¿ä°Ç
¼ºº°
¹«°ü
³ªÀÌ
¹«°ü
ÇзÂ
´ëÇÐ(4³â) Á¹¾÷
¡è
°æ·Â
3³â
¡è
¿ì´ëÁ¶°Ç
¿µ¾î°¡´ÉÀÚ, ÀϺ»¾î°¡´ÉÀÚ
ȸ»ç¸í
ºñ°ø°³
¾÷Á¾
Á¦¾àȸ»ç/µµ¸Å
±â¾÷ÇüÅÂ
¿Ü±¹°è±â¾÷
Á÷¿ø¼ö
500 ¸í
»óÀå¿©ºÎ
¹Ì»óÀå
»ó¼¼¸ðÁý³»¿ë
** ÀϺ»°èÁ¦¾àȸ»ç QM Specialist ä¿ë **
* QM Manager
1. ¾÷¹«³»¿ë
-. Establish and maintain an audit plan of KOP, including trial-specific and system audits, in collaboration with OPC Global QM and/or other Otsuka QM/QA departments, as appropriate.
-. Plan, prepare, conduct, report audits and follow-up corrective actions.
-. Conduct audits for clinical trial documents (protocol, informed consent form, clinical trial report and other documents as appropriate)
-. Conduct internal system audits.
-. Conduct external audits including clinical investigator sites and external service providers.
-. Conduct pre-inspection audits.
-. Manage regulatory inspections and audits by other companies.
-. Review, authorize and maintain KOP SOPs and WPs.
-. Provide or coordinate trainings in regards to SOPs/WPs, GCPs, and other relevant regulations and policies as needed.
-. Support, train and manage QM associate
-. Review and provide input into Otsuka Global/Regional SOPs to ensure harmonization.
2. ÀÚ°Ý¿ä°Ç :
-. Have strong analytical, interpersonal and communication skills.
-. Ideally have a working knowledge of KFDA regulations, GCPs, auditing procedures, drug development/research process and clinical research in general
-. Ability to develop and interpret policies and to perform multiple tasks
-. Accurate, well-organized, sincere, discreet and honest characteristics
-. Excellent written and oral communication skills
-. Good time management and prioritization skills regarding travel and other duties
-. Biological/science/pharmacy/nursing degree; advanced degree preferred
* QM Senior
1. ¾÷¹«³»¿ë
-. Support QM manager for planning, preparing, conducting, reporting audits and follow-up corrective actions.
-. Support QM manager to conduct internal system audits (including clinical study documents, such as Protocol, Study Report).
-. Support QM manager to conduct external audits including clinical investigator sites and external service providers.
-. Support QM manager to manage regulatory inspections and audits by other companies.
-. Review, update and maintain KOP SOPs and WPs.
-. Update and maintain Global SOPs
-. Prepare SOP training materials and provide or coordinate trainings in regards to SOPs/WPs, GCPs, and other relevant regulations and policies as needed.
-. Collaboration with Global QM and/or other Otsuka QM/QA departments
2. ÀÚ°Ý¿ä°Ç :
-. Have strong analytical, interpersonal and communication skills.
-. Ideally have a working knowledge of KFDA regulations, GCPs, auditing procedures, drug development/research process and clinical research in general
-. Ability to develop and interpret policies and to perform multiple tasks
-. Accurate, well-organized, sincere, discreet and honest characteristics
-. Excellent written and oral communication skills
-. Good time management and prioritization skills regarding travel and other duties
-. Biological/science/pharmacy/nursing degree; advanced degree preferred
Á¢¼ö±â°£
»ó½Ã¸ðÁý
Á¦Ãâ¼·ù
À̷¼, ÀÚ±â¼Ò°³¼
Á¢¼ö¹æ¹ý
À̸ÞÀÏ
À̷¼¾ç½Ä
Áö¿øÀÚ ÀÚÀ¯À̷¼ ¾ç½Ä
´ã´çÀÚ
±èº´Áø
¿¬¶ôó
02-2187-2033
Æѽº
02-2187-2005
À̸ÞÀÏ
roy.kim@reedglobal.com
ȨÆäÀÌÁö
http://www.reedglobal.co.kr
ȸ»çÁÖ¼Ò
[135-080] ¼¿ï °³²±¸ ¿ª»ïµ¿ 736-1 ijÇÇŻŸ¿ö Aµ¿ 20Ãþ
ÃÖÁ¾¼öÁ¤ÀÏ : 2012³â 03¿ù 01ÀÏ
º» Á¤º¸´Â (ÁÖ)·òµåÄÚ¸®¾Æ¿¡¼ Á¦°øÇÑ ÀÚ·áÀ̸ç, Æĸ¶¸ÞµðÀâ´Â(Àº) ±âÀçµÈ ³»¿ë¿¡ ´ëÇÑ ¿À·ù¿Í Áö¿¬, »ç¿ëÀÚ°¡ À̸¦ ½Å·ÚÇÏ¿© ÃëÇÑ Á¶Ä¡¿¡ ´ëÇÏ¿© Ã¥ÀÓÀ» ÁöÁö ¾Ê½À´Ï´Ù. º» Á¤º¸´Â Æĸ¶¸ÞµðÀâÀÇ µ¿ÀÇ ¾øÀÌ Àç¹èÆ÷ÇÒ ¼ö ¾ø½À´Ï´Ù.
¼±ÅÃÇϽŠÀ̷¼¿Í ÀÔ·ÂÇϽŠ³»¿ëÀÌ ÇØ´ç¾÷üÀÇ ´ã´çÀÚ¿¡°Ô À̸ÞÀÏ·Î Àü¼ÛµË´Ï´Ù.
Áö¿øÀ̷¼
À̷¼¸¦ ¼±ÅÃÇØÁÖ¼¼¿ä
´ã´çÀÚ¸í
±èº´Áø (roy.kim@reedglobal.com)
º¸³»´Â»ç¶÷
³»¿ë
°³ÀÎÁ¤º¸Ã³¸®¹æħ
|
ȸ¿ø¾à°ü
|
°í°´Áö¿ø¼¾ÅÍ
|
Á¦ÈÞ ¹× ±¤°í¹®ÀÇ
|
´ÙÀÌ·ºÆ®°áÁ¦
¼³¸³ÀÏ : 2015³â 12¿ù 02ÀÏ l °³ÀÎÁ¤º¸Ã¥ÀÓÀÚ : À±º´È£
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003
»ç¾÷ÀÚµî·Ï¹øÈ£ : 285-18-01963
| Åë½ÅÆǸž÷½Å°í : Á¦ 2023-ÀÎõ-0450È£
Copyright ¨Ï
Æĸ¶¸ÞµðÀâ
Co. Ltd. All rights reserved.