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Quality Assurance GMP Compliance (1 year contract) - 1³â °è¾àÁ÷

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Quality Operations in Product Supply (Ansung city)


2014-10-15 ~ 2014-10-20








¡Ü ¾÷¹«°³¿ä



¡Û   Tracks deviation related issues and makes final deviation documents and follows up its corrective & preventive actions if required. And controls deviation related documents(deviation report, related SOPs, guidelines)


¡Û  Plans annual audit schedule and proceeds audits according to the schedule. And prepares audit reports and follows up the findings. And based on audit report and quality data, prepares supplier evaluation documents.


¡Û  Plans annual training schedule for the production div. and performs basic GMP trainings for all production div. staffs. Checks training status of each department and controls training related documents


¡Û Review production batch records and QC testing records for final product release and coordinate batch release procedure. And review that QC testing worksheets including data spread sheets are prepared according to valid product license and QS/TS


¡Û  Prepares annual product review reports based on the batch records review data, deviations and changes implemented and checks all the data which required annual product review


¡Û Prepares related documents which requested to submit to authorities and coordinates authority inspections including update of site master files.


¡Û Initiates and coordinates a stability program according to the respective SOPs and review stability test data.


¡Û Checks and confirms that the goods are controlled properly according to KGSP and premises and equipment in Yongma warehouse are in a good and hygienic condition


 


 


 








¡Ü ÀÀ½ÃÀÚ°Ý


¡Û University graduate and majored in Chemistry


¡Û  Preferably a Pharmacist


¡Û  At least 2 year- experience in QA, especially for GMP & auditor training with understanding of GMP, Customer complaint handling, F/U Deviation report, prepare & review of SOP, etc.


¡Û  Cooperative attitude, reliability and inter-personal skill


¡Û  Good in communication and organizing tasks


¡Û  Sense of interdepartmental and interdisciplinary cooperation


¡Û  Analytical thinking


¡Û  Excellence in MS office program+Hangul


¡Û  English communication in written & verbal (if possible)








 


 


 


 


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