Senior Quality Assurance Specialist

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.