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Quality Assurance Manager
2 semanas atrás
Company Overview
Helm Ag is a unique family business and an attractive employer. Our ultimate goal is to offer our customers future-oriented solutions within our global network, at any time, in any place.
We are innovation drivers, possibility makers, and a reliable partner, all in one. As a quality-focused company, we strive to maintain the highest standards of quality management systems.
Job Summary
The Manager Quality Systems (m/f/d) will maintain all processes related to the Global Quality System to ensure compliance with GxP guidelines. The ideal candidate will have a strong understanding of GMP, GDP, GCP, and GLP regulations and experience in quality management systems.
Key Responsibilities
- Maintain and continually update the Global Document System to ensure it aligns with EU operating authorizations and licenses.
- Implement and oversee external document and process change control procedures to ensure seamless integration of updates.
- Manage the qualification process for suppliers and customers, including ongoing performance assessments with a focus on quality standards.
- Oversee the audit process, including planning, execution, and support, to ensure all audits are completed effectively and within set timelines.
- Maintain and enhance the CAPA system to address quality issues and prevent recurrence.
- Conduct audits of contracting companies, suppliers, and service providers worldwide, ensuring compliance with GMP and GDP regulations.
- Manage and maintain the quality training system to ensure training programs meet identified needs and GxP requirements.