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Set up site QMS (SOP /WI) strategy to be compliant to ISO 9001, ISO 13485. (Some of processes need to compliant to the pharma industry GMP and ISO14644, 11137)

•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

+ Melt local QMS to Sartorius global designated eQMS

+ Get ready for ISO 9001 certification audit and external customer audit as a supplier to the bio-process pharma customer

Qualification & Skills:

+ Bachelor’s degree in science related (Bio, Medical etc.)

+ Min. 10 years’ well-proven work experience in pharmaceutical/medical device industry QMS QA

+ Strong at document/record management

+ Experienced with health authority or notification body inspection/customer audit in healthcare industry

+ Fluent in English communication

+ Leadership experience managing small groups of more than 5 people

+ Excellence communication skills to facilitate cross functional organization

+ Work experience work in or with multinational healthcare industry

+ Experienced with eQMS and SAP based work environment

+ Self-motivated, entrepreneurship, enjoying exploring new technology (IT tools)

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