Data Integrity Ambassador: CSV & MES/BMS Lead

Lonza; Stein; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Competitive salary

Lifestyle & leisure benefits

Zusammenfassung

Lonza Stein in Switzerland seeks a Senior QA Expert CSV & Data Integrity to lead DI initiatives on-site, driving compliance for computerized systems and validation for MES and BMS. You will collaborate with global colleagues to ensure regulatory readiness and robust data integrity culture.

The role emphasizes on-site work with up to 20% remote time, enabling precise, real-time collaboration to support manufacturing of medicines at the highest quality standards in a growing site.

Qualifikationen

• Experience in QA within GMP-regulated environments.
• Expertise in CSV for MES and BMS systems.
• Strong deviation handling, change control and risk assessment skills.
• Fluent English; German is advantageous in regulatory contexts.

Aufgaben

• Act as Data Integrity Ambassador for the Stein site, leading DI assessments and driving compliance improvements.
• Lead validation activities for MES (MODA), BMS (DeltaV) and production/lab equipment lifecycle.
• Oversee computerized system validation for equipment and infrastructure, including CAPEX projects.
• Serve as the key QA contact for CSV, guiding validation strategies and documentation lifecycle.
• Collaborate with local/global teams to support audits, deviations, CAPAs and change controls.

Kenntnisse

Quality Assurance

GMP compliance

CSV

Deviation handling

Change management

Quality risk assessment

English proficiency

German language (advantage)

Tools

MODA MES

DeltaV

Jobbeschreibung

Lonza Stein in Switzerland seeks a Senior QA Expert CSV & Data Integrity to lead DI initiatives on-site, driving compliance for computerized systems and validation for MES and BMS. You will collaborate with global colleagues to ensure regulatory readiness and robust data integrity culture.

The role emphasizes on-site work with up to 20% remote time, enabling precise, real-time collaboration to support manufacturing of medicines at the highest quality standards in a growing site.