Quality & GxP Compliance 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

Quality and GxP compliance: QMS, audit support and audit-proof documentation in the life sciences.

You make sure engineering and validation work holds up in an audit, from contributing to the QMS through audit preparation and support.

Your responsibilities

• 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+).

Your profile

• 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.

What we offer

• Demanding projects on real GMP equipment in the life sciences.
• Short paths, flat hierarchies and real responsibility from day one.
• Work close to operations rather than from a distance, in a collegial engineering team.
• Fair, performance-based employment terms and continuing education.
• Strictly confidential. We treat your application in strict confidence. Without your consent, nobody finds out, not even a client.
• A conversation between engineers. The technical interview is an exchange between equals: no assessment, no standard questions.
• Straight to the founder. Your application goes straight to the founder, not into a portal.

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