Preparation of Qualification protocols for ETO projects as per cGMP- FAT/SAT,
Provide independent quality assurance review and approval of qualification documents, Knowledge on GDP, Strategic planning for qualification aiming to complete as per project timelines.
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.
Main Responsibilities & Tasks:
-
Create quality measurements to track improvement in products
-
Execute quality improvement testing and activities
-
Develop quality assurance standards and company processes
-
Conduct audits and keep reports to document all quality assurance activities
-
Adhere to industry quality and safety standards
-
Ensure products meet customer expectations and demand
-
Create reports documenting errors and issues for fixing
-
Work closely with the development team to improve existing products
-
Maintain standards for reliability and performance of production
Qualification & Skills:
-
Bachelor's degree in science or Engineering or
-
Minimum 3-5 Years related experience required in Manufacturing
-
Working knowledge of products and services
-
In-depth understanding of industry standards and company policies
-
Good customer focus
-
Sharp attention to detail
-
Strong analytical and problem-solving skills
-
Fluent in English
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
What We Do
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.
We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide.
With innovative laboratory instruments and consumables, the our 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 around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.
In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe.
Join our team, partner or collaborate with us.
