Senior QA Specialist (7167)

Senior QA Specialist: Cleanrooms Qualification & Environmental Monitoring

Join a global market leader in the production and process support of active pharmaceutical ingredients across the chemical and biotechnology sectors. This temporary opportunity, based in Visp, Switzerland, runs until 31.05.2027 and focuses on enhancing environmental monitoring performance qualification (EM PQ) and cleanroom hygiene standards.

You will provide Quality oversight, review monitoring results, support investigations into limit excursions, and collaborate with site teams to strengthen contamination prevention practices. This role welcomes candidates with relevant experience in Quality Assurance, Quality Control Microbiology, environmental monitoring, or cleanroom manufacturing, with cleanroom qualification experience viewed as a significant advantage.

Main 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.

Required Qualifications

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship.
• Bachelor’s degree in microbiology, biology, biotechnology, or a related scientific discipline, or an equivalent relevant qualification.
• 10+ years of 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.
• Clear communication and accurate documentation skills.
• A collaborative approach, sound judgment, and the ability to work independently and prioritize activities.
• Business fluent English.

Experience That Would Be a Plus

• Cleanroom qualification, particularly EM PQ.
• Investigation of environmental monitoring limit excursions and assessment of monitoring trends.
• Cleaning and disinfection practices, gowning, or other aspects of cleanroom hygiene.