Quality Systems Support Specialist m/f/w

The role is responsible for managing documentation processes and systems within the Quality organization, ensuring compliance with internal procedures and regulatory standards. It involves system ownership, user support, continuous improvement, and audit readiness.

Project title: Quality Systems Support Specialist m/f/w

Type of employment: Payroll

Industry: Biotech

Skills: QMS,Quality Engineering

Project start: 01.10.2025

Project duration: 31.12.2025

Location: Neuchâtel, Switzerland

Tasks:

System Ownership & User Support

• Act as system/process owner or administrator for assigned documentation systems
• Maintain documentation quality systems and archiving activities
• Provide user support and training; manage training materials
• Handle user account requests and document lifecycle (creation, approval, archiving)
• Escalate and communicate critical issues
• Maintain and update team SharePoint

Continuous Improvement & Site Initiatives

• Collaborate with local, global, and cross-site teams to improve systems
• Support business partners in identifying needs and implementing solutions
• Represent Quality in site projects and regulatory system deployments
• Contribute to site-wide initiatives and continuous improvement efforts

Compliance & Audit Support

• Support inspections, audits, and regulatory submissions
• Assist in preparing for Quality Councils and Gemba walks
• Coordinate collection of site Quality Metrics/KPIs
• Provide backup for other Quality Systems functions as needed

Qualifications:

• Degree in pharmaceutical sciences, life sciences, or related field
• Minimum 2 years in the (bio)pharmaceutical industry, preferably in a multinational environment
• Solid knowledge of GMP, regulatory guidelines (FDA, EMA, ICH), and Data Integrity principles
• Proficiency in electronic document management systems (e.g., Veeva Vault)
• Fluent in French and English (minimum B2 level)
• Skilled in Microsoft Office (Word, Excel, PowerPoint, SharePoint)