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QA Specialist( )
۷ι ȭǰ ȸ   2018-11-06
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- QA Specialist

 

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1) Quality Control and Compliance of OTC / Quasi drug

- Obtain and maintain the Health Authority required registration of OTC or QD Pharmacist

- Review and Batch Release Approval for OTC / QD based on J&J and Korea MFDS requirements

- Management of Master Product standard documents and specification of OTC / QD Management of CoA for OTC / QD

- Management of SOPs related with OTC / QD

- Management of GMP dossier of OTC / QD

- Support of self-inspection management and report to MFDS of OTC / QD

- Support of internal audit and AAP management for OTC / QD

- Support of management of the defect (complaint, NC and CAPA) for OTC / QD

 

2) Quality Control of KGSP and Distribution (DC)

- Quality control & Hygiene management of KGSP for Janssen OTC / QD products

- Quality compliance management of DC and Management of Training for KGSP Compliance

- Support consumer complaint management with related team and affiliates

 

3) External Laboratory Management

- External Laboratory management for OTC and Quasi drug

 

4) Regulatory Compliance

- Review and Management of related Law and regulation from Health Authority

 

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1) Bachelor's degree or above with pharmacist license holder -MUST

2) A minimum 1 year experience with knowledge of MFDS regulation, cGMPs, Quality Systems and product quality attributes. QA/QC compliance experience is preferred 

3) Good command of English for effective oral/written communication.

4) Strong interpersonal skills for influencing and collaboration

 

 

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- word () ̷¼ ± to lara@bbp.co.kr

 

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- A.S.A.P (ä )

 

*ڿ Ͽ 帱 عٶϴ.
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: 02-6925-3359
: 010-2543-4901
: lara@bbp.co.kr 

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02-6925-3359/010-2543-4901   lara@bbp.co.kr