work remotely anywhere in Europe What you will accomplish together with our customer Take responsibility for Outsourced Product Qualification maintenance and maintain outsourced product specifications including data base Create and maintain outsourced product items into SAP Maintain incoming testing plans among the sites and ensure consistency of incoming testing plan across the plant network Collaborate with procurement quality supplier engineers to execute supplier change control, to maintain supplier documentation needed for the outsourced product quality requirements and to act as a relay between PSNL and site quality teams PPAP maintenance, i.e.
statements, drawing update Ensure Internal supplier Quality Management (Sartorius as a supplier), both process execution and continuous improvement Where required, participate actively to definition of robust containment actions and CAPA definition to close gaps and secure launch What will convince our client A Bachelor's or a Master's degree in biology, engineering, or similar; higher degree optionalA Master´s degree in Engineering or Biotechnology Several years' experience in supplier quality management or in engineering center related role
- industries targeted biotech, pharma, excipients manufacturing or culture media manufacturing Strong GMP, Medical device & industry standards knowledge ( 21 CFRs/ ISO13485/ ICH Qs, ) Extended experience in auditing suppliers Strong supplier quality management system understanding Strong problem-solving methodologies knowledge - e.g.
8D, QRQC Fluency in English, German would be an asset Experience in international working environment Identification with our core values:
Sustainability, Openness, Enjoyment What we offer Opportunity for international career development:
a global network offering International career opportunities; A career in a company with above-average growth Open and highly collaborative culture:
mutual support within teams and a high team spirit Work-life balance:
Working from home Incredible dynamism in the company You can contribute your know-how and define and design processes yourself