Qualification & Validation / Equipment Relocation Consultant

Swisslinx AG; Schönenbuch; Vor Ort; CHF 150.000 - 190.000; Vollzeit

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

TrackWise Digital

Jobbeschreibung

We are looking for an experienced Qualification & Validation Consultant to support a production equipment relocation project within the In Vitro Diagnostics (IVD) environment.

You will support the planning, execution and documentation of equipment relocation and requalification activities, ensuring compliance with applicable GMP, ISO and regulatory requirements.

Requirements

• 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, gap and impact assessments
• Support commissioning, qualification testing and requalification following equipment relocation
• Plan and execute process and cleaning validation activities
• Support CSV activities where required
• Manage deviations, CAPAs and Change Controls
• Create and maintain Change Requests, Impact Assessments and Action Items within TrackWise Digital
• Ensure complete, audit-ready documentation in accordance with ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements
• Coordinate activities across cross-functional teams and support project planning, reporting and stakeholder management
• The equipment scope includes production and laboratory systems such as freeze dryers/lyophilizers, ELISA coating equipment, filling and incubation systems, cleanrooms, HVAC and purified water systems.

Competences

• 10+ years of experience within regulated Life Sciences environments
• 5+ years of experience with equipment relocation projects
• Previous experience within Diagnostics / IVD or Medical Devices
• Strong hands-on experience with equipment qualification and IQ/OQ/PQ
• Experience with process validation and cleaning validation
• Proven experience with TrackWise Digital
• Strong knowledge of ISO 13485, IVDR, GMP, GAMP 5, FDA 21 CFR Part 820, EU Annex 11 and Data Integrity requirements
• Experience with risk management and assessments, ideally according to ISO 14971
• Experience with freeze dryers/lyophilizers and/or ELISA coating equipment is highly advantageous
• Strong project coordination skills and experience working across multiple stakeholders and functions
• Structured, independent and quality-focused approach with strong documentation and communication skills

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