Quality Assurance Specialist

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Job Description

1.PURPOSE OF POSITON/ROLE

The overall responsibility is to support the operation of Quality function in Seoul Commercial site of South Korea ensuring compliance to local regulatory authority and Takeda’s global requirements for importation, repackaging, in-country testing, storage and distribution of all Takeda products marketed in the territory.

2.KEY ACCOUNTABILITIES AND RESPONSIBILITIES:

·Ensure the country specific QMS is compliant with the in-country regulations per licenses, and with Takeda global QMS.

·Coordinate AMT(Analytical Method Transfer) with global team and local contract laboratories.

·Manage the day-to-day operations of Product Quality including but not limited to: transport and distribution deviations, OOE/OOS in contract laboratory

·Making sure for local QC test to be timely prepared and performed for seamless product supply by communicating with manufacturing site, supply chain, contract laboratory and warehouse etc.

·Purchase and manage Reference standard, reagent and columns including RedCross relevant tasks

·Support to prepare required document for Batch record and support release

·Support QA oversight(supervision) of Takeda Distributor partner, including managing supplier audit, QTAs/Confidential agreement/QC service agreement, product launches. Critical change controls (If necessary), and qualification of customer.

·QA SOP preparation and its implementation according to Takeda Quality Management System and local regulation

·Document management and archive relevant documents to meet the Korea drug importer requirement.

·Manage and support of authority inspection regarding quality issue, self-inspection, CAPA, Change control, and annual product review.

·Coordinate & support audit for relevant parties in its business scope including HA audit and self-inspection.

RESPONSIBILITIES:

A.Essential responsibilities – 

Refer to “2. KEY ACCOUNTABILITIES AND RESPONSIBILITIES

B.Marginal responsibilities – 

N/A

3.EDUCATION, EXPERIENCE, AND SKILLS

Required Experience 

5 ~10 years in the pharmaceutical industry as QC and QA.

Good knowledge of pharmaceutical quality management systems

Knowledge of GMP/GDP in end-to-end manufacturing and supply chain

Proficiency in English, both written and verbal, to effectively communicate and collaborate with global and local contract lab

Locations

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