Certified Quality Assurance Specialist
vor 1 Woche
Solvias, a leading provider of integrated solutions in contract analytical research, development and manufacturing, seeks an experienced Quality Assurance professional to join its team at the Kaiseraugst site.
Job Summary:This role involves reviewing and approving quality documents, supporting quality investigations, maintaining corrective and preventive measures, performing internal audits, organizing customer audits, applying audit and compliance requirements, and serving as QA point of contact for customers.
Key Responsibilities:- Review and approval of SOPs, protocols, reports, certificates of analysis, and other quality documents
- Support quality investigation of deviations and out-of-specification events
- Maintenance, recording, and processing of CAPAs
- Performing internal audits to ensure adherence to GMP regulations
- Organizing and managing customer audits and inspections
- Applying and interpreting audit and compliance requirements
- Acting as QA point of contact for customers
- Scientific education (Master's degree) in analytical chemistry/biochemistry/life science
- Minimum 7 years' industrial experience in the analytical-pharmaceutical environment, preferably 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 an auditor is an asset
- Fluency in English and willingness to learn German is required
- Flexible work models such as part-time and remote work
- 28.5 vacation days per year
- Monthly child allowance above the Swiss minimum
- Voluntary monthly family allowance
- Pension fund solutions
- Daily allowance insurance and non-occupational accident fees paid by Solvias
- Reka cheques
- Commuter contribution for using public transport
- Employee discount programs for fitness, insurance, retail, and more
- Onsite canteen
The estimated salary for this position is around CHF 80,000 - CHF 110,000 per year, depending on qualifications and experience.
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