GxP Audit & Quality Engineer

Vispact; Lavamünd; Hybrid; EUR 42.000 - 56.000; Vollzeit

Zusammenfassung

Vispact in Austria seeks a QA/QC and GxP compliance specialist to support QMS activities and audit processes on GMP equipment. The role focuses on ensuring documentation and procedures meet regulatory standards.

You will contribute to audit preparation, deviations assessment, CAPA, and change control, while promoting data integrity (ALCOA+). German language skills are essential; English is an advantage in a collaborative engineering team.

Qualifikationen

• Degree in natural sciences, pharmacy or engineering.
• Experience in QA/QC or GxP compliance.
• Knowledge of GMP, Annex 1/11/15 and data integrity.
• Very good German; English an advantage.

Aufgaben

• Support on QMS topics and GxP compliance.
• Audit preparation and support, internally and at client sites.
• Assessment of deviations, CAPA and change control.
• Promoting data integrity (ALCOA+).

Kenntnisse

QA/QC

GxP compliance

Audit support

QMS

Data integrity

GMP knowledge

German language

Ausbildung

Degree in natural sciences, pharmacy or engineering

Jobbeschreibung

Vispact in Austria seeks a QA/QC and GxP compliance specialist to support QMS activities and audit processes on GMP equipment. The role focuses on ensuring documentation and procedures meet regulatory standards.

You will contribute to audit preparation, deviations assessment, CAPA, and change control, while promoting data integrity (ALCOA+). German language skills are essential; English is an advantage in a collaborative engineering team.