Senior Quality Assurance Manager
vor 1 Woche
We are seeking a highly experienced Senior Quality Assurance Manager to join our team in Basel, Switzerland. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:
- Review and approve SOPs, protocols, reports, and other quality-related documents.
- Maintain a high level of detail orientation and support investigations of deviations and out-of-specifications (OOS) issues.
- Develop and implement corrective and preventive measures (CAPAs).
- Serve as the primary point of contact for quality assurance matters with customers.
- Organize and manage customer audits and inspections, ensuring seamless communication with stakeholders.
- Apply and interpret audit and compliance requirements, including ICH, FDA, USAP, and Ph. Eur.
- Conduct internal audits and provide GMP training to team members.
To succeed in this role, you will need:
- A 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 regulatory frameworks, such as ICH, FDA, USAP, and Ph. Eur.
- Familiarity with data integrity, computerized systems, risk assessment, and project support.
- Excellent problem-solving skills and outstanding communication abilities to collaborate with team members and stakeholders.
- Prior auditing experience is an asset.
The estimated annual salary for this role is CHF 120,000 - CHF 150,000, depending on your level of experience and qualifications.
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