Senior QA Specialist (m/w/d)

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.

Type of employment: Payroll

Industry: Biotech

Skills: Quality Assurance,Fill and Finish

Project start: 01.08.2025

Project duration: 6 months

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)