Quality Assurance Manager (f/m)
Company information
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. With headquarters near Basel, Switzerland, over 700 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.
Are you looking for an exciting opportunity?
Your mission
- Review and approval of SOPs, protocols, reports, CoAs and other quality documents
- Support quality investigation of deviations and Out of Specification (OOS)
- Maintenance, recording and processing of corrective and preventive measures (CAPA)
- Performing internal audits
- Organization and participation in customer audits, inspections
- Apply and interpret audit and compliance requirements
- Act as QA point of contact for customers
- Support for GMP training
Who you are
- Scientific education (Master degree) in analytical chemistry/ biochemistry/ life science
- Multi-year, industrial work experience in the analytical-pharmaceutical environment preferably experience in QA
- Strong problem solving skills to meet business objectives
- Excellent interpersonal skills and team work spirit
- Ability to collaborate in a dynamic, cross-functional matrix environment
- Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
- Solid background in data integrity and computerized systems risk assessment and project support
- Experience as an auditor is an asset
- Fluency in English and wiliness to learn German is required
Our employees are very close to our hearts. Each individual can make a difference and develop both professionally and personally. Does this appeal to you?