Senior QA Specialist - 7167

CTC Resourcing Solutions; Oberwallis; Presencial; CHF 110.000 - 150.000; Jornada completa

Descripción de la vacante

CTC is a trusted partner in Life Sciences recruitment, helping companies hire top QA talent. Our client, a global leader in production and process support for APIs, seeks a Senior QA Specialist for a maternity cover role in Visp, Switzerland, until 31 May 2027.

The position centers on environmental monitoring, EM PQ, and cleanroom hygiene. You will oversee QA activities, review monitoring results, investigate limit excursions, and collaborate with site teams to strengthen contamination

Formación

• Swiss work permit or citizenship required.
• Bachelor's degree in microbiology, biology, biotechnology or related field.
• 10+ years of QA/QC microbiology/environmental monitoring/cleanroom manufacturing in pharma/biotech.
• GMP knowledge.
• Ability to review data, investigate issues and develop practical solutions.
• Clear communication and accurate documentation skills.
• Collaborative yet able to work independently and prioritize.
• Business fluent English.

Responsabilidades

• Provide Quality oversight for environmental monitoring, focusing on EM PQ as part of cleanroom qualification.
• Prepare and review environmental risk assessments, qualification protocols, reports, and trend reports.
• Review environmental monitoring results, identify adverse trends, and ensure follow-up of excursions.
• Support investigations into monitoring excursions and contamination incidents, including root cause assessment and CAPAs.
• Support cleanroom hygiene practices, including cleaning, disinfection, gowning, personnel behavior, and material transfers.
• Collaborate with Manufacturing, Quality Control, Engineering, and QA to address contamination risks and improve cleanroom control.
• Contribute to procedures, change assessments, and continuous improvement activities for environmental monitoring and cleanroom hygiene.
• Support regulatory inspections and customer audits within area of expertise.

Conocimientos

GMP knowledge

Data interpretation

Documentation

Communication

Independent working

English proficiency

Educación

Bachelor's degree in microbiology/biology/biotechnology or related field

Descripción del empleo

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Senior QA Specialist , Cleanrooms Qualification, Environmental Monitoring, Contamination Control Strategy - Maternity cover, based in Visp, Switzerland until 31.05.2027.

The position focuses on environmental monitoring, particularly environmental monitoring performance qualification (EM PQ), and cleanroom hygiene. 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. Experience in cleanroom qualification is a plus, rather than a prerequisite

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 required;
• 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 required

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.