Switzerland Job Openings
The Estée Lauder Companies
QA Engineer
Lachen
FULL TIME
October 9, 2024
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
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 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
Job: Quality Assurance - Supply Chain
Primary Location: CH-Lachen
Job Type: Standard
Schedule: Full-time
Shift: 1st (Day) Shift
Job Number: 2412115
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