QA Specialist: Contamination Control & GMP Facilities

Proclinical; Oberwallis; Presencial; CHF 90 000 - 130 000; Tempo integral

Resumo da oferta

Proclinical is seeking a QA Specialist to support contamination prevention and control strategies within manufacturing and support units. This role focuses on premises and utilities qualification, ensuring compliance with regulatory requirements and internal quality standards.

You will play a key role in maintaining facilities and utilities in a qualified and controlled state. Responsibilities include overseeing facility qualification, environmental monitoring, and microbiological control

Qualificações

• Bachelor's degree in microbiology or a related science field.
• GMP experience in QA/QC microbiology within biologics or pharma.
• Strong regulatory knowledge (FDA/EMA) and compliance mindset.
• Experience with environmental monitoring and clean utility systems.
• Excellent documentation, communication, and data analysis skills.

Responsabilidades

• Provide quality oversight for qualification of manufacturing facilities, including environmental monitoring.
• Ensure facilities and quality systems comply with internal standards and regulatory requirements.
• Develop action plans to address deficiencies and maintain microbiological quality across sites and processes.
• Analyze environmental monitoring data, identify trends, and implement corrective actions.
• Collaborate with cross-functional teams for contamination prevention in new products and changes.
• Lead investigations into contamination incidents, excursions, and deviations.
• Offer microbiological expertise to support CAPAs and change controls.
• Support regulatory inspections and customer audits as a subject matter expert.

Conhecimentos

GMP experience

Microbiology

Regulatory knowledge

Environmental monitoring

Documentation

Formação académica

Bachelor's degree in microbiology or related science

Ferramentas

Environmental monitoring equipment

Descrição da oferta de emprego

Proclinical is seeking a QA Specialist to support contamination prevention and control strategies within manufacturing and support units. This role focuses on premises and utilities qualification, ensuring compliance with regulatory requirements and internal quality standards.

You will play a key role in maintaining facilities and utilities in a qualified and controlled state. Responsibilities include overseeing facility qualification, environmental monitoring, and microbiological control