Lead GxP Vendor Qualification

Proclinical Staffing; Bern; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a Vendor Qualification Expert to support GxP supplier qualification activities, leading document reviews, audits, and change controls to ensure regulatory compliance for GMP-relevant equipment and services.

You will act as Quality Delegate, manage qualified vendors, coordinate risk-based decisions, and collaborate with internal and external stakeholders across global sites, with English as the working language.

Qualifikationen

• Degree in life sciences or engineering.
• MSc or equivalent preferred.
• Experience in quality assurance and regulatory compliance with GxP guidelines (Swissmedic, FDA, EU).
• Knowledge of GMP and global regulatory requirements.

Aufgaben

• Lead vendor qualification processes, including document review and audit execution.
• Ensure the qualification of vendors providing GxP-relevant equipment and services.
• Act as a Quality Delegate and Change Coordinator for Vendor Qualification Change Controls.
• Establish and maintain an overview of qualified and to-be-qualified vendors for the site.

Kenntnisse

Quality assurance

Regulatory compliance

GxP knowledge

Risk-based decisions

Stakeholder collaboration

Project-based work

English fluency

Ausbildung

Life sciences or engineering degree

MSc or equivalent preferred

Jobbeschreibung

Proclinical Staffing is seeking a Vendor Qualification Expert to support GxP supplier qualification activities, leading document reviews, audits, and change controls to ensure regulatory compliance for GMP-relevant equipment and services.

You will act as Quality Delegate, manage qualified vendors, coordinate risk-based decisions, and collaborate with internal and external stakeholders across global sites, with English as the working language.