Senior Quality Assurance Expert with Pharmaceutical Industry Experience

Vor 3 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Gi Group SA

We are seeking a highly skilled Senior Quality Assurance Expert to join our team in Basel, Switzerland. This is a full-time position offering an attractive salary package.

The ideal candidate will have a Master's degree in analytical chemistry, biochemistry, or life sciences and at least 7 years of experience in the analytical-pharmaceutical environment, preferably in quality assurance.

Key Responsibilities:
- Review and approve SOPs, protocols, reports, Certificate of Analysis, and other quality-related documents
- Conduct investigations of deviations and out-of-specifications (OOS) and maintain, record, and process corrective and preventive measures (CAPAs)
- Act as a Quality Assurance point of contact for customers and organize and manage customer audits and inspections
- Apply and interpret audit and compliance requirements, perform internal audits, and provide support for GMP training

Requirements:
- Fluency in English and German
- 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

Salary: The estimated annual salary for this position is €80,000 - €110,000 depending on qualifications and experience.

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