Senior QA Specialist
Vor 5 Tagen
We are seeking a highly skilled Senior QA Specialist to join our team at TN Switzerland. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality in our manufacturing facilities and processes.
About the Role:
- Provide quality oversight for the qualification of manufacturing facilities and clean utilities systems.
- Ensure facility and quality systems state of compliance with internal requirements and appropriate regulations.
- 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.
- Lead and guide investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures.
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.
- Fluency in English, ability to communicate in or willing to learn German.
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