Senior Quality Assurance Specialist

vor 13 Stunden


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

Gi Group SA is seeking a highly skilled Senior Quality Assurance Specialist to join their team in Basel, Switzerland. As a key member of the quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance across all aspects of the company.

Key Responsibilities:

  • Review and approve SOPs, protocols, reports, Certificate of Analysis, and other quality-related documents
  • Maintain a high sense of detail orientation and support investigations of deviations and out-of-specifications (OOS)
  • Process corrective and preventive measures (CAPAs) and maintain records thereof
  • Act as a Quality Assurance point of contact for customers
  • Organize and manage customer audits and inspections
  • Apply and interpret audit and compliance requirements
  • Perform internal audits and provide support for GMP training

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 with a preference for proven experience in Quality Assurance
  • Profound expertise in the regulatory framework in the GMP environment, including ICH, FDA, USAP, Ph. Eur.
  • Background in data integrity and computerized systems, risk assessment, and project support
  • Strong problem-solving skills and outstanding communication skills to collaborate with team members and stakeholders
  • Prior auditing experience is an asset

Compensation and Benefits:

The estimated salary for this position is CHF 90,000 - CHF 110,000 per annum, depending on experience. Additionally, Gi Group SA offers a comprehensive benefits package, including health insurance, pension plan, and paid time off.



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