Quality Systems Manager

3 semanas atrás


Carnaxide, Lisboa, Portugal HELM AG Tempo inteiro

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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