Senior QA Specialist - Environmental Monitoring & Hygiene (f/m/d)
Vue: 105
Jour de mise à jour: 29-03-2024
Catégorie: Ventes Conseil / Service client
Industrie:
le contenu du travail
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Our site in Visp, Switzerland, is growing, and for the Quality Systems & Services Organization, we are currently looking for a Senior QA Specialist - Environmental Monitoring & Hygiene. The successful candidate will support the end-to-end contamination control strategies within our site manufacturing and support units.
Key responsibilities:
- Develop and implement comprehensive cleaning, disinfection, and hygiene strategies to maintain the microbiological quality of the site facilities, utilities, processes, and products
- Ensure compliance with internal and external regulatory requirements, particularly in areas related to environmental monitoring, pharmaceutical and industrial hygiene (gowning, cleaning and disinfecting, personnel hygiene). Participate in developing action plans to correct deficiencies in these areas
- Analyze environmental monitoring data, including data related to hygiene practices, to identify trends. Implement adequate corrective actions to maintain environmental control
- Lead investigations into hygiene breaches, monitoring excursions, and contamination incidents. Provide expertise in microbiology to support investigations, CAPAs, and change control related to contamination prevention and control.
- Develop and deliver training programs to facility staff on environmental monitoring, contamination prevention, cleanroom behavior, gowning protocols, and hygiene best practices
- Act as a Pharmaceutical Microbiology subject matter expert during regulatory inspections and customer audits, demonstrating comprehensive knowledge in environmental monitoring, hygiene, and contamination control
Key requirements:
- Bachelor’s degree in a relevant scientific discipline (preferably in microbiology)
- Substantial GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience
- Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA)
- Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control strategy required
- Excellent written and oral communication to include accurate and legible documentation skills
- Fluency in English, ability to communicate in or willing to learn German.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Date limite: 13-05-2024
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