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We are currently looking for a Quality Assurance Engineer (W/M) based in home-office in France, Belgium, Spain or in Germany (based in Gottingen).
Reporting to Cell Culture Media quality assurance manager, the Quality Assurance Engineer is supporting site quality organizations on non conformities management, trouble shooting...
Grow with us – Your Responsibilities
KPI follow-up(CAPA, NC, OOS …)
Audits follow-up,
Support to sites' certification to ISO standards
Complaints and deviations support :- check application of the process- pilot process among the sites
Manage complaints to CMOs as well as notifications from and to CMO
Quality culture deployment
Where required, participate actively to definition of robust containment actions and CAPA definition to close gaps
Represent quality during audits on topics he / she was involved in.
What will convince us
Master degree in Engineering or biotechnology
Min. 7 years’ experience in production or in engineering center – industries targeted biotech, pharma, API/Excipients manufacturing or culture media.
Strong GMP, Medical device & industry standards knowledge ( 21 CFRs/ ISO13485/ ICH Qs,…)
Good knowledge in statistics ( e;g; MSA, IPC,... )
Strong FMEA / risk assessment knowledge
Strong problem solving methodologies knowledge – e.g. 8D, 6M,...
English fluent
Leadership, accountability, team work and assertiveness
Experience in international working environment
What we offer
Our ambition is to simplify progress in life science research and the biopharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. So that more people can obtain access to better medicine. Nearly 15,000 employees at more than 60 production and sales locations worldwide are committed to this vision. And together, we have grown strongly over the past years. Do you also want to contribute to our vision? Grow with us and benefit from working with a Global Player that has kept its familiar atmosphere:
Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration
Work-life balance: Working from home at many sites
Intelligent working environment: working in smart buildings with the latest technology and equipment
Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow even further.
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
to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal.
Here you will find the best application tips from our HR team.
Information on the application process can also be found in this video and under FAQ & Contact (https://www.sartorius.com/en/company/careers/faq) .
In this brochure (https://www.sartorius.com/resource/static/celum/202114/23_EN_Candidate_Booklet_Digital_web.pdf) you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog (http://www.sartorius.com/en/company/newsroom/blog) and our career website (http://www.sartorius.com/en/company/careers) .
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