GxP Compliance Expert — Audit, CAPA & QA Leader

Gi Group UK; Kaiseraugst; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Pharmaceutical Client in Switzerland seeks a qualified GxP Compliance Expert for a temporary assignment starting immediately. You will lead GxP compliance activities across the clinical supply chain and serve as SME for audits and inspections.

The role requires a degree in a relevant field, 6+ years of experience, fluency in German and English, and strong knowledge of cGMP and regulatory inspections (FDA/EMA). You will work with Veeva and Cornerstone systems.

Qualifikationen

• Degree in a relevant field with significant experience.
• At least 6 years of professional experience in GxP/compliance.
• Extensive knowledge of cGMP and regulatory inspections (FDA/EMA).
• Deep understanding of end-to-end supply chain and logistics.
• Strong interpersonal and communication skills; customer focus.
• Fluency in German and English, written and spoken.
• Proficient with Veeva, Cornerstone, and common MS Office tools.

Aufgaben

• Serve as SME for GxP and compliance topics, including system administration.
• Act as Audit/Inspection SME for Deliver for non-study examinations.
• Process deviations, CAPAs, changes, and process improvements.
• Own Quality KPIs for Deliver and regulatory compliance.
• Drive deviation management improvement processes.
• Provide comprehensive compliance expertise and conduct RCA.
• Oversee SOPs and regulated documents; manage knowledge transfer.
• Lead trend reporting on Quality and Compliance requirements.
• Implement GxP training and develop employees' GxP knowledge.

Kenntnisse

GxP compliance

Regulatory inspections

Audit & CAPA

End-to-end supply chain

Stakeholder communication

German language

English language

Quality management

Ausbildung

BA/MS/MBA in Supply Chain/Pharma/Biology/Chemistry/Engineering

Tools

Veeva

Cornerstone

MS Office

Visio

Google applications

Jobbeschreibung

Pharmaceutical Client in Switzerland seeks a qualified GxP Compliance Expert for a temporary assignment starting immediately. You will lead GxP compliance activities across the clinical supply chain and serve as SME for audits and inspections.

The role requires a degree in a relevant field, 6+ years of experience, fluency in German and English, and strong knowledge of cGMP and regulatory inspections (FDA/EMA). You will work with Veeva and Cornerstone systems.