Senior Quality Assurance Manager
vor 15 Stunden
We are seeking a seasoned Quality Assurance Manager to join our team in Basel, Switzerland.
Responsibilities:- Review and approve standard operating procedures (SOPs), protocols, reports, certificates of analysis, and other quality-related documents.
- Maintain a high level of detail orientation and support investigations of deviations and out-of-specifications (OOS) occurrences.
- Record and process corrective and preventive measures (CAPAs).
- Serve as the primary point of contact for quality assurance matters with customers.
- Provide exceptional customer service, organizing and managing customer audits and inspections.
- Apply and interpret audit and compliance requirements.
- Conduct internal audits and offer support for Good Manufacturing Practice (GMP) training.
- A scientific education, such as 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 with proven experience in quality assurance.
- Deep expertise in the regulatory framework within the GMP environment, including ICH, FDA, USAP, and Ph. Eur.
- Familiarity with data integrity and computerized systems, risk assessment, and project support.
- Excellent problem-solving skills and outstanding communication skills to collaborate effectively with colleagues and stakeholders.
- Experience as an auditor is an asset.
The estimated salary for this position is approximately €80,000 per year, based on industry standards in Basel, Switzerland.
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