Senior Quality Assurance Specialist with Regulatory Expertise
vor 1 Woche
We are seeking an experienced Senior Quality Assurance Specialist to join our team at Solvias AG. As a key member of our quality assurance department, you will play a vital role in ensuring the highest standards of quality and compliance within our organization.
About the RoleAs a Senior Quality Assurance Specialist, you will be responsible for reviewing and approving SOPs, protocols, reports, and other quality documents to ensure they meet regulatory requirements. You will also support quality investigations of deviations and out-of-specification results, maintain and process corrective and preventive measures, and perform internal audits.
In addition, you will be responsible for organizing and managing customer audits and inspections, applying and interpreting audit and compliance requirements, and acting as the QA point of contact for customers. Your expertise in GMP regulations, including ICH, FDA, USP, and Ph. Eur., will be essential in ensuring our products meet the highest standards of quality and safety.
Requirements- A Master's degree in analytical chemistry, biochemistry, or life science
- Minimum 7 years of industrial work experience in the analytical-pharmaceutical environment, preferably in quality assurance
- 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
At Solvias AG, we offer a comprehensive benefits package that includes:
- Flexible work models, such as part-time and remote work
- Minimum 28.5 vacation days
- Monthly child allowance above the Swiss minimum
- Voluntary monthly family allowance
- Various 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 CHF 80,000 - 100,000 per year, depending on experience.
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