GxP Compliance Expert - Remote 2 Days/Week, Audits & CAPAs

Randstad Switzerland; Kaiseraugst; Hybrid; CHF 140.000 - 190.000; Teilzeit

Benefits dieser Stelle

Home office 2 days/week

12-month contract with possible ext.

Zusammenfassung

Randstad Switzerland is seeking a GxP Compliance Expert for a leading pharmaceutical client. You will act as SME on GxP and regulatory topics with a focus on the clinical supply chain, audits, CAPAs, and process improvements. Fluency in German and English is required.

You will manage deviations, CAPAs, and SOP governance while implementing RCA-driven improvements and delivering quality KPIs. The role offers home-office flexibility up to two days per week and a 12-month contract with potential

Qualifikationen

• University degree in a relevant field (e.g., Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering & Management).
• At least 6 years of professional experience in GxP compliance and related audit/inspection activities.
• Extensive knowledge of cGMP standards and experience with internal and external regulatory inspections (FDA, EMA).
• Deep understanding of end-to-end supply chain management including warehouse, transportation, logistics, and clinical distribution.
• Fluent in German and English, strong communication and organizational skills.
• Proficient with Google applications, MS Office (Word, Excel, PowerPoint), Visio, Veeva, Cornerstone.

Aufgaben

• Serve as SME for GxP and compliance topics, including system administration (Veeva quality docs).
• Audit/Inspection SME for deliverables and inspections.
• Process deviations, CAPAs, changes, and process improvements.
• Own Quality KPIs for Deliver and drive trend reporting across Quality and Compliance.
• Lead RCA to address quality and regulatory issues.
• Oversee SOPs and regulated documents, ensuring business knowledge captured by SMEs.
• Develop and deliver GxP training to employees.

Kenntnisse

GxP compliance

Regulatory inspections

Root Cause Analysis

Quality KPI ownership

Audit/Inspection SME

Deviation/CAPA management

Supply chain end-to-end

Communication skills

German & English fluency

Ausbildung

BA/MS/MBA in Supply Chain Management/Logistics or related fields

Tools

Veeva

Cornerstone

MS Office

Visio

Google applications

Jobbeschreibung

Randstad Switzerland is seeking a GxP Compliance Expert for a leading pharmaceutical client. You will act as SME on GxP and regulatory topics with a focus on the clinical supply chain, audits, CAPAs, and process improvements. Fluency in German and English is required.

You will manage deviations, CAPAs, and SOP governance while implementing RCA-driven improvements and delivering quality KPIs. The role offers home-office flexibility up to two days per week and a 12-month contract with potential