Senior Quality Assurance Specialist
vor 13 Stunden
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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