Quality Assurance Engineer

ARTO; Oberwallis; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

ARTO in Switzerland is seeking a QA Validation Specialist for a 6-month contract to oversee validation activities in pharma manufacturing. You will coordinate qualification tasks, review pipelines for IQ, temperature mapping, and clean utilities, and contribute to CAPAs and regulatory readiness.

Applicants should have 4+ years in GMP CQV, hands-on IQ and qualification experience, and be fluent in English; German is a plus.

Qualifikationen

• Bachelor’s degree in a scientific or technical field.
• 4+ years of pharmaceutical GMP experience with direct exposure to CQV.
• Hands-on experience with equipment qualification (IQ), temperature mapping, clean utilities and validation activities.
• Experience with Kneat and TrackWise is highly desirable.
• Fluent English is required; German is a strong advantage.
• Must be able to work in Switzerland.

Aufgaben

• Provide QA oversight for validation activities and coordinate daily qualification tasks.
• Develop, review and approve qualification protocols and reports (IQ, autoclaves, clean utilities, shipping validation, temperature mapping, etc.).
• Review and approve SOPs, Change Controls, Deviations and CAPAs using systems such as TrackWise, Kneat, DMS and LIMS.
• Perform change control assessments and support FDA/EMA regulatory inspections and audits.

Kenntnisse

QA oversight

CQV experience

GMP

IQ validation

Temperature mapping

TrackWise

Kneat

LIMS

Ausbildung

Bachelor’s degree in a scientific or technical field

Tools

Kneat

TrackWise

Jobbeschreibung

QA Validation Specialist - Switzerland - 6 Month Contract

This is an exciting opportunity for an experienced QA Validation Specialist to join a leading pharmaceutical organisation on a 6-month contract supporting cutting‑edge pharma manufacturing processes.

If you're looking for an engaging mission in Switzerland and have strong QA oversight and Commissioning, Qualification & Validation (CQV) experience within a GMP environment then this may be the move for you!

Key Responsibilities:

• Provide QA oversight for validation activities and coordinate daily qualification tasks.
• Develop, review and approve qualification protocols and reports (IQ, autoclaves, clean utilities, shipping validation, temperature mapping, etc.).
• Review and approve SOPs, Change Controls, Deviations and CAPAs using systems such as TrackWise, Kneat, DMS and LIMS.
• Perform change control assessments and support FDA/EMA regulatory inspections and audits.

Requirements:

• Bachelor’s degree in a Scientific or Technical field.
• 4+ years of pharmaceutical GMP experience with direct exposure to CQV.
• Hands‑on experience with equipment qualification (IQ), temperature mapping, clean utilities and validation activities.
• Experience with Kneat and TrackWise is highly desirable.
• Fluent English is required; German is a strong advantage.
• Must be able to work in Switzerland

If you're an experienced QA Validation professional looking for your next contract within an innovative Cell & Gene Therapy environment, I'd be happy to discuss the opportunity further.