Audit & Inspection QA Expert | Remote (up to 20%)

Lonza Group; Stein (AR); Hybrid; Vertraulich; Full time

Job summary

Lonza is seeking a quality-inspection coordinator to support audits and regulatory inspections at our Stein, AG site in Switzerland. The role involves back-office coordination, preparation, hosting activities, logistics, and documentation to ensure smooth audit execution.

It offers exposure to international inspections and opportunities to grow in quality and regulatory fields. The position is primarily on-site with the flexibility to work remotely up to 20% of time and occasional travel to

Qualifications

• Bachelor's or Master's degree in Life Sciences with GMP experience.
• Fluent English; able to interact with global stakeholders and authorities.
• Experience with audits/inspections and CAPA management is preferred.

Responsibilities

• Coordinate and support regulatory inspections and customer audits.
• Act as back-office partner during audits, ensuring timely responses and coordination.
• Drive follow-up activities in TrackWise and develop CAPA plans with SMEs.
• Contribute to inspection readiness for a sterile filling facility and promote quality excellence.
• Support GMP compliance and QMS activities (change controls, deviations, CAPAs, self-inspections).

Skills

GMP knowledge

Audit coordination

English fluent

Stakeholder collaboration

Education

Bachelor's/Master's in Life Sciences

Tools

TrackWise

Job description

Lonza is seeking a quality-inspection coordinator to support audits and regulatory inspections at our Stein, AG site in Switzerland. The role involves back-office coordination, preparation, hosting activities, logistics, and documentation to ensure smooth audit execution.

It offers exposure to international inspections and opportunities to grow in quality and regulatory fields. The position is primarily on-site with the flexibility to work remotely up to 20% of time and occasional travel to