Senior QA Specialist
vor 3 Wochen
Senior QA Specialist (Hybrid) - Microbiological Quality Assurance and Contamination Control
Hybrid: Working Model (3 days in the office, 2 days WFH)
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.
The role:
For our biggest site in Visp in Switzerland, we are looking for a Senior QA Specialist, Microbiological Quality Assurance and Contamination Control who will have a high impact ensuring the quality of our manufacturing facilities, processes, products and collaborate virtually with all functions at the site. You will support the end-to-end contamination control strategies within our site manufacturing and support units.
Key responsibilities:
- Provide Quality oversight for the qualification (environmental monitoring PQ) of manufacturing facilities and PQ of clean utilities systems.
- Ensure facility and quality systems state of compliance with internal requirements and appropriate regulations and participate in developing action plans to correct deficiencies to ensure the adequate microbiological quality of the site facilities, utilities, processes, and products.
- Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions.
- Collaborate with cross-functional teams to ensure microbial contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes.
- Lead and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures. Provide microbiological expertise to support Investigations, CAPAs, and Change Control related to Contamination Prevention and Control.
- Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, and hygiene best practices.
- Support regulatory inspections and customer audits as a Pharmaceutical Microbiology subject matter expert.
Experience and skill required:
- 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 microbial control strategy required.
- 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.
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