CSV Engineer - GAMP 5 Data Integrity Lead

Vispact; Schweiz; Hybrid; EUR 96.000 - 138.000; Vollzeit

Benefits dieser Stelle

Challenging GMP projects

Flat hierarchies

Hands-on responsibility from day one

Continuing education

Confidential application process

Zusammenfassung

Vispact, a life sciences engineering firm, seeks a CSV specialist to validate computerized systems in a GxP environment, focusing on data integrity from the outset. You’ll apply GAMP 5 (2nd edition) with risk-based reasoning and contribute to lifecycle data integrity (ALCOA+).

Responsibilities include CSV activities to GAMP 5, risk-based categorisation, supplier assessment, test design, and change control with periodic review. German proficiency is essential; English is a plus.

Qualifikationen

• Degree in computer science, engineering, natural sciences or similar.
• Experience with CSV in a GxP environment.
• Knowledge of GAMP 5, data integrity and Annex 11.
• Very good German; English an advantage.

Aufgaben

• CSV activities to GAMP 5 (2nd edition), risk-based.
• Categorisation, supplier assessment and test design.
• Ensuring data integrity (ALCOA+) across the lifecycle.
• Change control and periodic review.

Kenntnisse

Risk-based thinking

Data integrity (ALCOA+)

GAMP 5 knowledge

German language

English language

Ausbildung

Degree in computer science, engineering, natural sciences or similar

Jobbeschreibung

Vispact, a life sciences engineering firm, seeks a CSV specialist to validate computerized systems in a GxP environment, focusing on data integrity from the outset. You’ll apply GAMP 5 (2nd edition) with risk-based reasoning and contribute to lifecycle data integrity (ALCOA+).

Responsibilities include CSV activities to GAMP 5, risk-based categorisation, supplier assessment, test design, and change control with periodic review. German proficiency is essential; English is a plus.