¾È³çÇϼ¼¿ä?
Ä¿¸®¾îÄɾî ÀÇ·áÁ¦¾à Àü¹®ÄÁ¼³ÅÏÆ® ¾È¼±°æÀÔ´Ï´Ù.
±Û·Î¹ú Á¦¾àȸ»çÀÇ QA Associate Æ÷Áö¼ÇÀÌ ¿ÀÇÂµÇ¾î ¾Æ·¡¿Í °°ÀÌ ¾È³»µå¸³´Ï´Ù.
1. ±Ù¹«È¸»ç ¹× ¸ðÁýºÎ¹® : ±Û·Î¹ú Á¦¾àȸ»ç QA Associate
1) Job Purpose:
To guarantee the quality of products and services for the Company
To ensure that affiliate operations are conducted to an adequate level of quality in conformity with regulatory and internally defined standards
2) Principal Tasks:
i) Manage local Quality Documents(QDs) issued by each concerned affiliate function through an appropriate affiliate QD management system, as a minimum for GxP and related health regulated.
ii) Manage Product Technical Complaints received by the affiliate according to defined Quality Standards & processes and in connection with Global Quality Functions and other relevant units.
iii) Manage product-related quality events (quality alerts/recalls/notifications to & from local Health Authorities) according to defined Quality Standards & processes and in connection with Global Quality Functions.
iv) Define and monitor relevant Key Quality Performance Indicators.
v) Carry-out periodic(annual as a minimum) affiliate quality reviews(meetings) and issue periodic(at least yearly) associated quality reports and distribute to Affiliate Management and Global Operations Quality.
vi) Liase with each concerned affiliate function to ensure the availability of administrative records for regulated positions(updatedCV/job description/ training log and updated Organizational Chart)
vii) Ensure that appropriate, accurate & up-to-date signed quality agreements are in; lace with any external contractor for all GxP and health regulated activities, and ensure quality oversight of locally managed third-party suppliers/subcontractors for all GxP and health-regulated activities.
viii) Manage change controls in collaboration with regulatory affairs
ix) Management of Medical device importation
x) AQO role
-Perform batch/product release
-Be affiliate focal point for Quality Risk Management
-Ensure management/coordination of inspections by Regulatory Authorities, with collaboration of relevant functions at the country level and support Corporate Quality functions in the preparation, conduct & follow-up of audits of affiliate systems
2. Áö¿ø ÀÚ°Ý¿ä°Ç :
Pharmacist
Bachelor¡¯s degree or above in Science
1-5 years QA/QC experience in pharmaceutical industries
Knowledge about local pharmaceutical regulations and quality assurance system
Knowledge about KGMP and cGMP
3. ±Ù¹«È¯°æ
Á¤±ÔÁ÷
±Ù¹«Áö ¼¿ï
¿ù±Þ¿©, ¿¬ºÀÀº ÃßÈÄ ÇùÀÇ
4. Áö¿ø¹æ¹ý
ÇѱÛ/¿µ¹® À̷¼(°æ·Â »ó¼¼ ¼³¸í)¿Í ÀÚ±â¼Ò°³¼¸¦ À̸ÞÀÏ·Î ¾Æ·¡ÀÇ ´ã´çÀÚ¿¡°Ô Á¦ÃâÇϼ¼¿ä.
´ã´çÀÚ: Ä¿¸®¾îÄɾî ÀÇ·áÁ¦¾à Àü¹®ÄÁ¼³ÅÏÆ® ¾È¼±°æ
ask@careercare.co.kr
02-2286-3947
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003