IVD Equipment Relocation & Qualification Lead

Swisslinx AG; Zürich; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Swisslinx AG in Zürich seeks an experienced Qualification & Validation Consultant to support a production equipment relocation project in the In Vitro Diagnostics (IVD) environment. You will plan, execute and document relocation, qualification, and requalification activities, ensuring GMP, ISO and regulatory compliance.

The engagement covers cross-functional coordination, risk assessments, and TrackWise documentation, with focus on ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements.

Qualifikationen

• 10+ years of experience in regulated Life Sciences environments.
• Experience coordinating equipment relocation projects.
• Strong documentation and regulatory knowledge (ISO 13485, IVDR, GMP, GAMP 5, FDA).

Aufgaben

• Plan and coordinate equipment relocation, qualification and validation activities.
• Develop and execute DQ, IQ, OQ and PQ documentation.
• Prepare relocation and validation strategies, risk assessments and impact assessments.
• Support commissioning, qualification testing and requalification after relocation.
• Plan and execute process and cleaning validation activities.
• Manage deviations, CAPAs and Change Controls.

Kenntnisse

Life Sciences industry experience

Equipment relocation

Regulated environments

Cross-functional coordination

Tools

TrackWise Digital

Jobbeschreibung

Swisslinx AG in Zürich seeks an experienced Qualification & Validation Consultant to support a production equipment relocation project in the In Vitro Diagnostics (IVD) environment. You will plan, execute and document relocation, qualification, and requalification activities, ensuring GMP, ISO and regulatory compliance.

The engagement covers cross-functional coordination, risk assessments, and TrackWise documentation, with focus on ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements.