Global Sterility Assurance Systems & Standards Specialist
CSL Behring
Sterility assurance standards
Microbial contamination control strategy
Regulatory and csl standards adherence
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
Job Summary
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site.
Ensures appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
Matching Summary
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
Skills & Requirements
Must-have
Sterility Assurance standards
microbial contamination control strategy
regulatory and CSL standards adherence
sterile filtration and aseptic filling
inspection readiness
CMO and filling strategies support
Nice-to-have
strategic leadership
continuous improvement culture
holistic approach
proactive role in investigations
Key Requirements
Bachelor's degree in Microbiology or Biology or life sciences
8-10 years' experience in pharmaceutical manufacturing
quality assurance within manufacturing and QC microbiology