IVD Equipment Relocation & Validation Lead

Swisslinx AG

Schönenbuch

Vor Ort

CHF 150.000 - 190.000

Vollzeit

vor 39 Stunden

Sei unter den ersten Bewerbenden

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Zusammenfassung

Swisslinx AG in Basel-Landschaft seeks an experienced Qualification & Validation Consultant to support an equipment relocation project within the IVD environment. You will plan, execute and document relocation and requalification activities to ensure GMP, ISO and regulatory compliance.

The ideal candidate has deep hands-on experience with IQ/OQ/PQ, validation strategies, risk assessments, and TrackWise Digital, coordinating cross-functional teams and delivering audit-ready records.

Qualifikationen

10+ years in regulated Life Sciences environments.
Experience with equipment relocation projects in Diagnostics/IVD.
Hands-on qualification and validation across IQ/OQ/PQ.
Experience with process and cleaning validation.
Familiarity with regulatory standards and audits.

Aufgaben

Plan and coordinate equipment relocation, qualification and validation activities.
Develop and execute URS, DQ, IQ, OQ and PQ documentation.
Prepare relocation and validation strategies, risk assessments, FMEAs and gap analyses.
Support commissioning, qualification testing and requalification after relocation.
Plan and execute process and cleaning validation; support CSV activities.
Manage deviations, CAPAs and Change Controls; maintain TrackWise records.
Ensure audit-ready documentation per ISO 13485, IVDR, GMP, GAMP 5 and FDA.

Kenntnisse

Equipment relocation projects

IQ/OQ/PQ

Validation strategy

Risk assessments

TrackWise Digital

GMP / GAMP 5 / FDA knowledge

ISO 13485 / IVDR awareness

Cross-functional coordination

Documentation quality

Tools