QA Engineer

With more than 20 brands Estée Lauder Companies is the global leader in prestige beauty, recognized for its skincare, make-up, fragrances, and hair care products. In Switzerland, Estée Lauder has the main Supply Chain Hub for Travel Retail (TR) and EMEA. We are now looking for a QA Engineer to join our QA team based in Lachen, Switzerland.

Main responsibilities:

• Monitor and assure compliance to Good Manufacturing Practices (GMP) and adherence to defined procedures
• Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines and good practices
• Develop and implement quality standards and quality control systems
• Monitor and analyze quality performance
• Develop corrective actions, and solutions, and drive for continuous improvement, making use of lessons learned
• Analyze, investigate, and troubleshoot product or production issues to ensure closure in accordance with company
• guidelines and regulatory requirements Participate in new product introductions and lead and/or support validation programs of equipment and processes
• Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems
• Manage complaint program and monitoring for trends, coordinate requirements of investigation from site when required
• Implement and enforce policies, procedures, and standards. Provide training and support to quality team on systems and processes
• Perform process audits to assess compliance and ensure site audit readiness. Coordinate external Audit preparation
• Participate in supplier improvement activities and lead them on-site Quality side
• Lead, support and track the implementation of China Regulations

• Bachelor level degree in Quality, Engineering, technical field or equivalent.
• Minimum 3 years of quality experience in a regulated industry ideally in the manufacturing environment
• Proactive and hands-on mentality to get the job done, able to manage change with the ability to overcome resistance and persist in archiving a mission
• Strong analytical and problem-solving skills (Six sigma certification is a plus)
• Experience in quality management systems, process improvement utilizing statistical techniques, and quality tools
• Working experience with process validation (IQ, OQ, PQ) and SPC is a plus
• Experience in interpreting and assessing operational compliance against Good Manufacturing Practice Regulations (like ISO22716, FDA), knowledge of OTC Manufacturing a plus
• Excellent project management skills
• Knowledge of statistical sampling, AQL/ANSI interpretation, technical drawings/specifications and compounding/assembly instructions
• Ability and willingness to create and review SOPs and work instructions
• Previous audit experience
• Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and SAP systems is preferred
• Full professional proficiency in German and English 

Is this position relevant and interesting for you?  Then apply online now!