Senior QA Specialist - Contamination Control (7-Month)

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp is seeking a Senior QA Specialist for a 7-month, site-based contract. You will safeguard contamination control and oversee EMPQ and clean utilities with a focus on regulatory readiness. The role requires leading investigations, CAPA closures, and representing the site in customer audits and FDA/EMA inspections.

Ideal candidates bring 5+ years in GMP-biopharma QA, PQS experience, and strong environmental monitoring expertise, with English fluency and German being a plus.

Qualifikationen

• GMP experience in biologics/pharma required.
• 2+ years in Pharmaceutical Quality Systems (PQS), deviation management, CAPAs, and change controls.
• Experience with Environmental Monitoring Performance Qualification (EMPQ) and clean utilities.
• Degree in Microbiology or related science.
• Fluent written and spoken English; German a plus.

Aufgaben

• Ensure manufacturing facilities and clean utilities meet regulatory standards to deliver safe biopharmaceuticals.
• Provide QA oversight for premises and utilities qualification including EMPQ.
• Lead cross-functional investigations into monitoring excursions and deviations; define CAPAs.
• Represent site during customer audits and FDA/EMA inspections.
• Collaborate with operations teams to support new product introductions and facility changes.
• Analyze environmental monitoring data to identify trends and drive preventive actions.
• Drive continuous improvement of contamination control strategies and quality systems.

Kenntnisse

GMP experience

QA/Quality Assurance

Regulatory knowledge

EMPQ experience

CAPA & deviations handling

Audit readiness

English proficiency

German language skills (plus)

Ausbildung

Microbiology degree

Jobbeschreibung

Lonza in Visp is seeking a Senior QA Specialist for a 7-month, site-based contract. You will safeguard contamination control and oversee EMPQ and clean utilities with a focus on regulatory readiness. The role requires leading investigations, CAPA closures, and representing the site in customer audits and FDA/EMA inspections.

Ideal candidates bring 5+ years in GMP-biopharma QA, PQS experience, and strong environmental monitoring expertise, with English fluency and German being a plus.