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Senior QA Specialist (m/w/d) (EN)
[16391]
Quality Assurance, Fill and Finish
As a Senior QA Specialist, you will support the implementation of a new Fill & Finish and Visual Inspection area and contribute to routine GMP operations. You'll ensure compliance with cGMP standards, manage deviations, and maintain high-quality documentation. Project title: Senior QA Specialist (m/w/d) Type of employment: Payroll Industry: Biotech Skills: Quality Assurance,Fill and Finish Project start: 01.08.2025 Project duration: 6 months Location: Neuenburg, Schweiz Key Responsibilities ·QA support for new Fill & Finish/Visual Inspection setup ·Oversight of routine GMP activities in sterile production ·Review and approval of GMP documents (SOPs, protocols) ·Deviation and CAPA management in TrackWise ·Ensure data integrity and compliance with regulatory standards ·Support audits, batch reviews, GMP tours, and process improvements ·Maintain training compliance and system access rights Qualifications ·Master’s degree (or equivalent) in a scientific field ·2–3 years' QA experience in GMP sterile manufacturing ·Strong knowledge of production processes and quality systems ·Proficient in French and English (written and spoken)
- QA support for new Fill & Finish/Visual Inspection setup
- Oversight of routine GMP activities in sterile production
- Review and approval of GMP documents (SOPs, protocols)
- Deviation and CAPA management in TrackWise
- Ensure data integrity and compliance with regulatory standards
- Support audits, batch reviews, GMP tours, and process improvements
- Maintain training compliance and system access rights
- Master’s degree (or equivalent) in a scientific field
- 2–3 years' QA experience in GMP sterile manufacturing
- Strong knowledge of production processes and quality systems
- Proficient in French and English (written and spoken)
Luca Furler