GxP Vendor Qualification Lead - Pharma

We make it GmbH; Lavamünd; Vor Ort; EUR 95.000 - 127.000; Vollzeit

Zusammenfassung

CSL Behring AG in Bern seeks a Vendor Qualification Associate to lead GxP supplier qualification activities and audit execution. The role supports qualification of vendors for GxP-relevant equipment and services at the site level.

The position requires a life sciences or engineering degree (advanced degree preferred), 5+ years in pharma, and strong knowledge of GMP and regulatory guidance including US FDA and EU. English fluency is essential.

Qualifikationen

• Degree in life sciences or engineering; advanced degree preferred.
• 5+ years in pharmaceutical industry or equivalent.
• Experience in quality assurance and regulatory compliance with GxP, Swissmedic, FDA, TGA, EU.
• Direct experience in quality oversight of GxP vendor qualification processes.
• Strong communication and cross-functional collaboration skills.
• Fluent in English (spoken and written).

Aufgaben

• 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.

Kenntnisse

GxP compliance

Vendor qualification

Audits

Regulatory knowledge

Quality assurance

Ausbildung

Life sciences degree

Engineering degree

MSc preferred

Tools

GxP documentation systems

Audit tools

Jobbeschreibung

CSL Behring AG in Bern seeks a Vendor Qualification Associate to lead GxP supplier qualification activities and audit execution. The role supports qualification of vendors for GxP-relevant equipment and services at the site level.

The position requires a life sciences or engineering degree (advanced degree preferred), 5+ years in pharma, and strong knowledge of GMP and regulatory guidance including US FDA and EU. English fluency is essential.