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 eq...