Data Integrity QA Lead – CSV for MES & BMS (GMP)

Lonza

Lavamünd

Vor Ort

Vertraulich

Vollzeit

Vor 6 Tagen

Sei unter den ersten Bewerbenden

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Eine zielgenaue Bewerbung für diesen Job — ein maßgeschneiderter Lebenslauf und ein Anschreiben, die genau zur Stellenanzeige passen.

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Benefits dieser Stelle

Agile career

Inclusive workplace

Performance-based compensation

Lifestyle & family benefits

Zusammenfassung

Lonza in Stein, Switzerland seeks a Data Integrity Ambassador to lead DI assessments, drive compliance culture, and validate computerized systems for MES (MODA) and BMS (DeltaV) across production and lab equipment. On-site role with up to 20% remote work, global collaboration, and rigorous quality standards.

You will partner with local and international teams to strengthen data integrity, support audits, manage deviations and CAPAs, and ensure systems remain inspection-ready throughout their

Qualifikationen

Experience in GMP-regulated QA environments and pharmaceutical quality systems.
Hands-on CSV expertise including MES/BMS validation and lifecycle management.
Strong deviation handling, change management, and quality risk assessment skills.
Fluent English and collaboration in international teams.

Aufgaben

Serve as the Data Integrity Ambassador for the Stein site, leading DI assessments and driving compliance initiatives.
Lead CSV activities for MES (MODA) and BMS (DeltaV) and ensure systems are compliant and inspection-ready.
Oversee validation of computerized systems for equipment and infrastructure including CAPEX projects.
Act as QA contact for CSV, guiding validation strategies, documentation lifecycle, and regulatory compliance.
Partner with local and global teams to drive continuous improvement and support audits.

Kenntnisse

Quality Assurance

CSV Expertise

CSV Lifecycle

GMP Knowledge

English Fluent

Teamwork

Tools

MODA MES

DeltaV BMS

Jobbeschreibung