Quality Assurance Manager

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.

Key Responsibilities

  • Review and approve SOPs, protocols, reports, and other quality-related documents to ensure compliance with regulatory requirements.
  • Support investigations of deviations and out-of-specifications (OOS) to identify root causes and implement corrective actions.
  • Maintain, record, and process corrective and preventive measures (CAPAs) to ensure continuous improvement.
  • Act as a Quality Assurance point of contact for customers, providing technical support and guidance on quality-related matters.
  • Organize and manage customer audits and inspections to ensure compliance with regulatory requirements.
  • Apply and interpret audit and compliance requirements to ensure that our products and services meet regulatory standards.
  • Perform internal audits and provide support for GMP training to ensure that our employees are aware of quality-related requirements.

Requirements

  • A scientific education (Master's degree) in analytical chemistry, biochemistry, or life sciences.
  • Fluency in English and German.
  • At least 7 years of experience in the analytical-pharmaceutical environment, preferably in Quality Assurance.
  • Profound expertise in the regulatory framework in the GMP environment, including ICH, FDA, USAP, and Ph. Eur.
  • Background in data integrity and computerized systems, risk assessment, and project support.
  • Excellent problem-solving skills and outstanding communication skills to collaborate with team members and stakeholders.
  • Experience as an auditor is an asset.

Company Information

Gi Group SA is a leading staffing and recruitment agency, providing temporary and permanent staffing solutions to clients across various industries.

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