GMP Data Integrity Specialist (CSV) – Lab IT

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, seeks a Specialist - Data Integrity / CSV for the Quality Control team. The role covers laboratory computerized systems lifecycle, ensuring GMP compliance and system reliability across IT and lab stakeholders.

You will drive data integrity, qualification and validation efforts, and support cross-functional projects to uphold high quality standards in a regulated environment.

Qualifikationen

• Ph.D., Master’s degree, or comparable qualification in natural sciences, computer science, engineering, or a related field; equivalent practical GMP laboratory experience may be considered.
• Experience with Quality Risk Management in accordance with ICH Q9, data and process mapping.
• Strong understanding of data integrity and data governance in GMP-lab environments.

Aufgaben

• Ensure lifecycle activities for GMP-relevant laboratory computerized systems including qualification and validation.
• Coordinate software qualification, validation, administration and lifecycle activities with QA, IT, vendors and users.
• Create, maintain and update SOPs and work instructions within the assigned area.

Kenntnisse

Analytical Reasoning

Data Analysis

Quality Control

Quality System Documentation

Compliance Management

Continuous Improvement

ISO 9001

Execution Focus

Persistence and Tenacity

Report Writing

Sample Testing

Technologically Savvy

Controls Compliance

Data Integrity

Ausbildung

Ph.D., Master’s degree, or comparable qualification in natural sciences, computer science, engineering, or a related field

Tools

Microsoft Office

Jobbeschreibung

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, seeks a Specialist - Data Integrity / CSV for the Quality Control team. The role covers laboratory computerized systems lifecycle, ensuring GMP compliance and system reliability across IT and lab stakeholders.

You will drive data integrity, qualification and validation efforts, and support cross-functional projects to uphold high quality standards in a regulated environment.