GxP Compliance Expert | Quality & Audits Lead

Work Selection AG; Kaiseraugst; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

On-site parking

Meals in staff restaurants

Professional onboarding program

Staff discounts

Fleet discounts

Zusammenfassung

Work Selection AG seeks a GxP Compliance Expert for a 12-month assignment at its partner, Roche in Kaiseraugst. The role includes SME guidance on GxP topics, audits, and deviation management within a robust quality framework.

Ideal candidates hold a relevant degree and 6+ years in cGMP, with fluency in German and English, and strong MS Office, Veeva, Cornerstone skills. On-site work with onboarding days and development opportunities.

Qualifikationen

• Degree in a relevant field (e.g. Supply Chain Mgmt, Pharmacy, Biology, Chemistry).
• Significant senior experience (6+ years).
• Knowledge of cGMP standards and regulatory inspections (FDA/EMA).
• Strong cross-functional collaboration and stakeholder management.

Aufgaben

• Serve as SME for GxP and compliance topics, incl system administration (Veeva docs).
• Act as Audit/Inspection SME for non-study examinations.
• Process deviations, CAPAs, changes and process improvements.
• Own Quality KPIs for Deliver and drive trend reporting.
• Lead deviation management improvement initiatives and RCA actions.
• Provide comprehensive compliance expertise to address quality and regulatory issues.
• Maintain SOPs and regulated documents across the department.
• Support GxP training and development of staff knowledge.

Kenntnisse

GxP Compliance

Interpersonal skills

Communication skills

Organisational skills

Prioritisation

Ausbildung

BA/MS/MBA in a relevant field

Tools

Veeva

Cornerstone

Google Apps

MS Office

Visio

Jobbeschreibung

Work Selection AG seeks a GxP Compliance Expert for a 12-month assignment at its partner, Roche in Kaiseraugst. The role includes SME guidance on GxP topics, audits, and deviation management within a robust quality framework.

Ideal candidates hold a relevant degree and 6+ years in cGMP, with fluency in German and English, and strong MS Office, Veeva, Cornerstone skills. On-site work with onboarding days and development opportunities.