QAA | ¤ýÀü¹ÝÀûÀÎ Quality °ü¸® ¹× À¯Áö ¤ýSOP Á¦/°³Á¤ Æ÷ÇÔ SOP °ü¸® ¤ýAudit ½Ç½Ã (Internal System, Project, etc.) ¤ý¿ÜºÎ Vendor Æò°¡ ¹× °ü¸® ¤ýÀÇ·ÚÀÚÀÇ Audit ¹× Inspection ´ëÀÀ ¤ýIssue/Non¤ýcompliance °ü¸® ¹× CAPA ¼öÇà ÃßÀû ¤ý»ç³» ±³À° ¼öÇà (OJT, SOP/GCP training, ÀÓ»ó½ÃÇèÁ¾»çÀÚ±³À° µî) ¤ý±× ¿Ü assignµÇ´Â Quality management ¾÷¹« | ¤ý°£È£ÇÐ, ¾àÇÐ, »ý¸í°úÇÐ µî »ý¸í°úÇÐ °ü·Ã Çлç ÀÌ»ó ¤ýÀÓ»ó ½Ç¹«(CRA, PM) ¶Ç´Â QA/QC ¾÷¹« °æ·Â 5³â ÀÌ»ó ¤ýGood knowledge of ICH¤ýGCP, KGCP, and regulatory requirements ¤ýTime and priorities management skills ¤ýGood communication skills ¤ýQA °æ·Â, Auditor °æÇèÀÚ ¿ì´ë |
Trainer | ¤ý»ç³» ±³À° °èȹ, ¼öÇà, Æò°¡, º¸°í µî Àü¹ÝÀûÀÎ °ü¸® ¹× ¼öÇà (OJT, SOP/GCP training, ÀÓ»ó½ÃÇèÁ¾»çÀÚ±³À° µî) ¤ýÀÓ»ó½ÃÇè Àü¹Ý ¹× ±³À°¿¡ ´ëÇÑ ÇàÁ¤ ¾÷¹« (LMS °ü¸®, ½Ä¾àó º¸°í µî) ¤ýPersonnel Dossier °ËÅä ¹× °ü¸® ¤ý±× ¿Ü assignµÇ´Â Quality management ¾÷¹« | ¤ý°£È£ÇÐ, ¾àÇÐ, »ý¸í°úÇÐ µî »ý¸í°úÇÐ °ü·Ã Çлç ÀÌ»ó ¤ýÀÓ»ó ½Ç¹«(CRA, PM) ¶Ç´Â QA/QC ¾÷¹« °æ·Â 5³â ÀÌ»ó ¤ýGood knowledge of ICH¤ýGCP, KGCP, and regulatory requirements ¤ýTime and priorities management skills ¤ýGood communication skills ¤ý QA °æ·Â, Trainer °æÇèÀÚ ¿ì´ë *¸éÁ¢ Àü¿¡ ½Ã° ÀÚ·á Á¦ÃâÀ» ¿äû µå¸³´Ï´Ù. (¼·ù ÇÕ°ÝÀÚ º°µµ ¾È³» ¿¹Á¤) |