Quality Systems Manager
3 semanas atrás
The Quality Systems Manager at HELM AG maintains all processes related to the Global Quality System to ensure compliance with GxP guidelines. This role requires a deep understanding of GMP, GDP, GCP, and GLP standards.
Your key responsibilities:
- Maintain and update the Global Document System to align with EU operating authorizations and licenses.
- Ensure compliance with GxP guidelines, including GMP, GDP, GCP, and GLP standards.
- Implement and oversee external document and process change control procedures.
- Manage the qualification process for suppliers and customers, including ongoing performance assessments.
- Oversee the audit process, including planning, execution, and support.
- Maintain and enhance the CAPA system to address quality issues and prevent recurrence.
- Conduct audits of contracting companies, suppliers, and service providers worldwide to ensure compliance with GMP and GDP regulations.
- Manage and maintain the quality training system to ensure training programs meet identified needs and GxP requirements.
Your profile:
- You hold a degree in Pharmacy, Life Sciences, Chemistry, or a related field, with relevant experience in quality management systems.
- You demonstrate a solid understanding of GxP guidelines, including GMP, GDP, GCP, and GLP, to ensure compliance with regulatory standards.
- You have proven ability to maintain and continually update a Global Document System in alignment with EU operating authorizations and licenses.
- You can implement and manage external document and process change control procedures to ensure seamless integration of changes.
- You oversee the qualification process of suppliers and customers, including ongoing performance assessments with a focus on quality standards.
- You manage audits effectively, including planning, execution, and support, ensuring they are completed within set timelines.
- You maintain and enhance the CAPA system to address quality issues and prevent recurrence.
- You handle the quality training system, ensuring training programs meet GxP requirements and department-specific needs.
- You are able to communicate fluently in English.
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