QMS Specialist

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Additional Information

Responsible for the site QMS procedure and strategy to be compliant to ISO 9001, ISO 13485. (Some of process to be compliant to pharma industry GMP) Responsible for the site QMS procedure and strategy to be compliant to ISO 9001, ISO 13485. (Some of process to be compliant to pharma industry GMP) Main Responsibilities & Tasks: Create and maintain local QMS SOP compliant with ISO 13485 and applicable Sartorius Global procedures (Change control, QI/NC, CAPA, Internal Audit, Supplier management, Management Review etc.) Analyze gap between different levels of global procedures to prepare best-harmonized local procedures Get ready for ISO 9001 certification audit and external customer audit as a supplier to the bio-process pharma customer. Interfaces: Local: As a site quality almost, all functions are internal customer and counter-part Global: Occasionally this person needs to contact equivalent scope of other Sartorius site people mainly located in France, German, US and China. Qualification & Skills: Bachelor's degree in science or quality related (Bio, Medical etc.) 3~5 years' well-proven work experience in healthcare (Pharmaceutical/medical device industry) as a QA Strong in document/record management skills. Experienced with regulatory body inspection/customer audit in healthcare industry. Fluent English communication capability Professional people management experience and skill Good command of both English and Korean About Sartorius Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers

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