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Quality Assurance Engineer - Home-office based (F/M)
We are looking to a Quality Assurance Engineer based in home-office.
Reporting to Cell Culture Media quality assurance manager, the quality assurance engineer is supporting site quality organizations on non conformities management, trouble shooting...
What you will accomplish together with us
- 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.
- 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
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.