Quality Assurance Manager
vor 2 Monaten
Job Summary:
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lonza. As a key member of our quality assurance department, you will be responsible for ensuring the quality of our manufacturing facilities, processes, and products.
Key Responsibilities:
- Provide quality oversight for the qualification of manufacturing facilities and clean utilities systems.
- Ensure facility and quality systems are in compliance with internal requirements and regulations, and participate in developing action plans to correct deficiencies.
- Analyze and interpret environmental monitoring data, identify trends, and implement 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.
- 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.
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 microbial control strategy required.
- Fluency in English, ability to communicate in or willing to learn German.
About Lonza:
Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives through innovative solutions and responsible business practices. Our people are our greatest asset, and we offer a dynamic and inclusive work environment that fosters creativity, collaboration, and growth.
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