Quality Assurance Specialist

vor 2 Wochen

Lachen SZ, Schwyz, Schweiz Estée Lauder Companies Vollzeit
Job Summary

We are seeking a skilled QA Engineer to join our team in Lachen, Switzerland.

About the Role

In this position, you will be responsible for monitoring and assuring compliance to Good Manufacturing Practices (GMP) and adherence to defined procedures. You will maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines, and good practices.

Main Responsibilities
  • 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
Qualifications
  • 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 achieving 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

The estimated salary for this role is around CHF 80,000 - 120,000 per year, depending on experience.

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