GxP Compliance Expert & Audit Lead

ITech Consult AG; Kaiseraugst; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

ITech Consult AG seeks a senior GxP and quality compliance expert to guide the business in regulatory topics and inspections. You will oversee deviations, CAPAs, changes, and process improvements while managing SOPs and regulated documents. Training will raise the team’s GxP knowledge across the organization.

The role requires a degree in a relevant field and at least six years of senior experience, with fluency in German and English. You will work within a Swiss environment in Kaiseraugst.

Qualifikationen

• Degree in a relevant field with extensive senior experience.
• Strong knowledge of cGMP and regulatory inspections.
• Fluent German and English, excellent communication skills.

Aufgaben

• Provide proactive advice on GxP and compliance topics, incl. system administration.
• Own quality KPIs and deviations, CAPAs, changes and process improvements.
• Lead deviation management improvements and root cause analysis.
• Manage SOPs and regulated documents across the department.
• Deliver training to enhance employees' GxP knowledge and compliance.

Kenntnisse

GxP Compliance

Audit Management

CAPA & Deviation Handling

Ausbildung

BA/MS/MBA in a relevant field

Tools

Veeva

MS Office

Jobbeschreibung

ITech Consult AG seeks a senior GxP and quality compliance expert to guide the business in regulatory topics and inspections. You will oversee deviations, CAPAs, changes, and process improvements while managing SOPs and regulated documents. Training will raise the team’s GxP knowledge across the organization.

The role requires a degree in a relevant field and at least six years of senior experience, with fluency in German and English. You will work within a Swiss environment in Kaiseraugst.