Quality Assurance Manager 80% (m/f/d)
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 800 highly qualified employees take pride in 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, Certificate of Analysis and other quality documents
- Support quality investigation of deviations and Out of Specification (OOS)
- Maintenance, recording and processing of corrective and preventive measures (CAPA)
- Organization and management of customer audits, and inspections
- Apply and interpret audit and compliance requirements
- Act as QA point of contact for customers
- Support for GMP training
- System Administration of Quality Management Software
Requirements
- Scientific education (Master degree) in analytical chemistry/ biochemistry/ life science
- Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment preferably experience in QA
- Strong problem-solving skills to meet business objectives
- Excellent interpersonal skills and teamwork 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 system administrator or deeper IT knowledge is an asset
- Fluency in English and wiliness to learn German is required
- a well-structured onboarding program
- intensive training in the beginning
- the possibility for further development
- flexible working time models
- 40 hours week
- at least 28.5 vacation days per year (depending on your age)
- commuter contribution for using public transport
- staff restaurant