Senior QA Specialist – Cleanroom & Environmental Monitoring

Coopers Group; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Coopers Group in Visp, Switzerland seeks a QA specialist with 6+ years in environmental monitoring and cleanroom environments. You will oversee GMP-compliant environmental monitoring, review data and risk assessments, and support investigations into excursions and contamination events.

The role emphasizes collaboration with Manufacturing, QA, and Engineering to improve cleanroom control and hygiene, and to prepare for regulatory inspections and customer audits.

Qualifikationen

• Bachelor’s degree in microbiology, biology, biotechnology, or related field or equivalent qualification.
• 6+ years in QA, QC Microbiology, environmental monitoring or cleanroom manufacturing in pharma/biotech.
• Practical understanding of environmental monitoring and GMP requirements.

Aufgaben

• Provide quality oversight for environmental monitoring, focusing on EM PQ in cleanroom qualification.
• Support preparation and review of environmental risk assessments, qualification protocols, reports, and trend reports.
• Review monitoring results, identify adverse trends, and ensure follow-up of excursions.
• Support investigations into excursions and contamination incidents, including root cause assessment and CAPA.
• Support cleanroom hygiene, including cleaning, disinfection, gowning, and material transfers.
• Collaborate with Manufacturing, QC, Engineering, and QA to address contamination risks.
• Contribute to procedures, change assessments, and continuous improvement in monitoring and hygiene.
• Support regulatory inspections and customer audits within area of expertise.

Kenntnisse

Quality Assurance

Quality Control Microbiology

Environmental Monitoring

GMP Knowledge

Root Cause Analysis

Data Interpretation

Ausbildung

Bachelor's degree in microbiology or related field

Jobbeschreibung

Coopers Group in Visp, Switzerland seeks a QA specialist with 6+ years in environmental monitoring and cleanroom environments. You will oversee GMP-compliant environmental monitoring, review data and risk assessments, and support investigations into excursions and contamination events.

The role emphasizes collaboration with Manufacturing, QA, and Engineering to improve cleanroom control and hygiene, and to prepare for regulatory inspections and customer audits.