Vendor Qualification Associate

About the role

We Make It GmbH, a national Swiss personnel services company, is recruiting on behalf of its customer CSL Behring, a manufacturer of drugs for immune deficiency and rhesus prophylaxis and of albumin solutions, based in Bern. The position is a Vendor Qualification Associate with standard working hours of 41 hours per week for a period of 6 months.

Key responsibilities

• Execute GxP supplier qualification activities
• Lead vendor qualification, including document review and audit execution
• Ensure qualification of vendors supplying GxP-relevant equipment and services
• Act as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls
• Maintain an overview of qualified and to-be-qualified vendors for site BRN

Required profile

• Degree in life sciences and/or engineering; advanced degree (M.Sc. or equivalent) preferred
• 5+ years of experience as a professional in the pharmaceutical industry, or an equivalent combination of education and experience
• Demonstrated experience in quality assurance and regulatory compliance with GxP, Swissmedic, US FDA, TGA, EU and other regulatory agencies, and in manufacturing of biologics
• Direct experience overseeing GxP-compliant vendor qualification processes, including planning, documentation review and audit execution
• Experience in project-based work
• Fluent English, spoken and written

Required skills

• Deep knowledge of GMP and global regulatory requirements (GMP, FDA, EU)
• Risk-based decision-making in a quality environment
• Strong communication and influence across all organizational levels
• Excellent organizational and interpersonal skills and effective collaboration with internal and external stakeholders

Applications are submitted by e-mail to the recruiter, Mr. Raphael Sigg, with CV, certificates and training certificates.