QA Specialist (m/f/d) 100%

For Lonza AG in Visp we are looking for a QA Specialist (m/f/d) 100%. This role is temporary for a minimum of 6 months.

Lonza in Visp, Switzerland, is one of the company's largest sites and a key hub for innovation and production. The site specializes in the development and manufacturing of pharmaceutical ingredients, biopharmaceuticals, and chemical intermediates. With a broad range of technologies and services, Lonza Visp supports clients in the pharmaceutical, biotechnology, and specialty chemicals sectors, providing tailored solutions for drug and specialty product manufacturing. The site plays a central role in Lonza's global value chain and drives innovation in the life sciences industry.

Key responsibilities:

• Verification of the company's compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices
• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams
• Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations
• Independently identify and manage special projects or QA compliance functions as agreed upon with QA management
• Review and approve validation documents

• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience
• GMP compliance and Part 11 compliance knowledge preferred
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations
• Excellent written and oral communication to include accurate and legible documentation skills
• The ability to interface and communicate directly with clients is required