Senior Quality Assurance Specialist

Coopers Group AG; 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

Location

Visp

Contract start date

immediately

Contract end date

31 May 2027

Responsibilities

• Provide Quality oversight for environmental monitoring, with a particular focus on EM PQ as part of cleanroom qualification.
• Support the preparation and review of environmental risk assessments, qualification protocols, reports, and trend reports.
• Review environmental monitoring results, identify adverse trends, and ensure appropriate follow-up of alert and action limit excursions.
• Support investigations into monitoring excursions and contamination incidents, including root cause assessment and corrective and preventive actions.
• Support cleanroom hygiene practices, including cleaning and disinfection, gowning, personnel behavior, and material transfers.
• Collaborate with Manufacturing, Quality Control, Engineering, and Quality Assurance to address contamination risks and improve cleanroom control.
• Contribute to procedures, change assessments, and continuous improvement activities related to environmental monitoring and cleanroom hygiene.
• Support regulatory inspections and customer audits within your area of expertise.

Requirements

• Bachelor’s degree in microbiology, biology, biotechnology, or a related scientific discipline, or an equivalent relevant qualification.
• 6+ years of Experience of relevant experience in Quality Assurance, Quality Control Microbiology, environmental monitoring, or cleanroom manufacturing in a pharmaceutical or biotechnology environment.
• Practical understanding of environmental monitoring, microbiological contamination control, and cleanroom hygiene.
• Working knowledge of Good Manufacturing Practice (GMP) requirements.
• Ability to review and interpret data, investigate issues, and develop practical solutions.