The Quality Assurance Specialist will be responsible for ensuring that products and services meet the established standards set by the company. The goal is to maintain strong overall quality control of products made by the company adhering to reliability, performance and customer expectation.
[GMP Quality Systems]
* Manage GMP Quality Management Systems (QMS), including document control, change control, and training management.
* Manage and maintain laboratory and manufacturing equipment.
* Perform environmental monitoring activities.
* Ensure and maintain data integrity compliance.
Qualifications
* Bachelor's degree or higher.
* Entry-level candidates and experienced professionals are both welcome.
* Strong understanding of GMP regulations and quality systems.
* Experience or knowledge related to GMP quality system operations.
* Ability to understand English documentation and communicate effectively in English.
Preferred Qualifications
* Experience implementing and operating GMP electronic systems such as eQMS and eDMS.
* Experience in risk assessment and data integrity management.
* Experience supporting inspections by domestic and international regulatory authorities.
* Experience responding to audits and inspections conducted by regulatory agencies.
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
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.
We help our customers simplify progress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are part of the solution in the fight against diseases worldwide.
With innovative laboratory instruments and consumables, the Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes.
The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically.
Based in Göttingen, Germany, Sartorius also has a strong global reach with more than 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.
In 2024, Sartorius generated sales revenue of around 3.4 billion euros. Currently, more than 13,500 employees from around 110 nations are working for customers around the globe.
Join our team, partner or collaborate with us.
