Quality Assurance Manager 80% (m / f / d)
Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy, and Cosmetic industries. Headquartered near Basel, Switzerland, with over 800 highly qualified employees, Solvias prides itself on putting science at the heart of serving customers to bring safer and better products to market faster.
Job Description
* Review and approval of SOPs, protocols, reports, Certificates of Analysis, and other quality documents.
* Support quality investigations of deviations and Out of Specification (OOS) results.
* Maintain, record, and process corrective and preventive measures (CAPA).
* Organize and manage customer audits and inspections.
* Apply and interpret audit and compliance requirements.
* Act as QA contact for customers.
* Support GMP training initiatives.
* System administration of Quality Management Software.
Requirements
* Master's degree in analytical chemistry, biochemistry, or life sciences.
* Minimum of 7 years of industrial experience in the analytical-pharmaceutical environment, preferably with QA background.
* Strong problem-solving skills to meet business objectives.
* Excellent interpersonal skills and team spirit.
* Ability to collaborate in a dynamic, cross-functional matrix environment.
* Broad knowledge of and proven experience with regulatory frameworks in GMP (ICH, FDA, USP, Ph. Eur.).
* Solid background in data integrity, computerized systems, risk assessment, and project support.
* Experience as a system administrator or IT knowledge is an asset.
* Fluency in English and willingness to learn German.
Additional Benefits
* Structured onboarding program.
* Intensive training at the beginning.
* Opportunities for further development.
* Flexible working time models.
* 40-hour workweek.
* At least 28.5 vacation days per year (depending on age).
* Public transport commuter contribution.
* Staff restaurant.
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