Qualification & Validation / Equipment Relocation Consultant

Job-Room; Zürich; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Swisslinx AG is seeking an experienced Qualification & Validation Consultant to support an equipment relocation project in the IVD environment. You will plan, execute and document relocation, qualification and validation activities to ensure GMP/ISO compliance.

Requirements include 10+ years in regulated Life Sciences, experience with DQ/IQ/OQ/PQ, TrackWise Digital, and risk assessments. Strong cross-functional collaboration and documentation skills are essential for success in this role.

Qualifikationen

• 10+ years of experience in regulated Life Sciences environments.
• 5+ years with equipment relocation projects.
• Experience in Diagnostics/IVD or Medical Devices.
• Hands-on equipment qualification IQ/OQ/PQ.
• Process and cleaning validation experience.
• Experience with TrackWise Digital.
• Knowledge of ISO 13485, IVDR, GMP, GAMP 5, FDA 21 CFR Part 820, EU Annex 11 and Data Integrity.
• Experience with ISO 14971 risk management.
• Familiarity with freeze dryers/lyophilizers or ELISA coating equipment.
• Strong coordination across stakeholders.
• Structured, independent documentation skills.

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, FMEAs, gap and impact assessments.
• Support commissioning, qualification testing and requalification after relocation.
• Plan and execute process and cleaning validation.
• Support CSV activities.
• Manage deviations, CAPAs and Change Controls.
• Create and maintain Change Requests, Impact Assessments and Action Items within TrackWise Digital.
• Ensure audit-ready documentation per ISO 13485, IVDR, GMP, GAMP 5 and FDA requirements.
• Coordinate activities across cross-functional teams and assist project planning and stakeholder management.

Kenntnisse

Life Sciences experience

Equipment relocation

Documentation

Project coordination

Cross-functional teamwork

Tools

TrackWise Digital

Jobbeschreibung

Job description

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.

About the customer

• Location: Switzerland
• Start: As soon as possible
• Duration: Approx. 6–9 months
• Workload: 80-100%

Requirements

• 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, 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

Swisslinx AG Löwenstrasse 29 8001 Zürich