Expert Vendor Qualification (m/f/d)

Expert Vendor Qualification (m/f/d)

Freelance/Contracting project Bern Start date: asap Reference number: 893731/1

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Responsibilities

• Execute GxP supplier qualification activities
• Lead vendor qualification including document review and audit execution
• Ensure qualification of vendors providing GxP-relevant equipment and services
• Act as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls
• Establish and Maintain Overview of already Qualified and to be Qualified Vendors for Site BRN

Profile

• Degree in life sciences and/or engineering
• Advanced degree ( or equivalent) preferred
• Extensive experience as professional in the pharmaceutical industry or equivalent combination of education and experience
• Demonstrated experience in quality assurance and regulatory compliance with GxP, Swissmedic, US FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics
• Direct experience in quality oversight of GxP-compliant vendor qualification processes, including planning, documentation review, and audit execution
• Efficient, risk-based decision-making in a quality environment
• Deep knowledge of GMP and global regulatory requirements, GMP, FDA, EU and other relevant GxP regulations as well as Experience in project-based work
• Strong communication and influence across all organizational levels
• Excellent organizational and interpersonal skills as well as effective collaboration with internal and external stakeholders
• Fluent in English (spoken and written)

Benefits

• A highly motivated team and an open way of communication
• Central location
• Flat hierarchies
• Professional and trusting cooperation
• We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position
• We will give you valuable tips and feedback on your application documents and interviews