Catalent Pharma Solutions - Harmans, MD
posted 30 days ago
The Manager, Sterility Assurance will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for Gene Therapy Drug Substance and Drug Product Operations. This individual should be able to work independently with little direction to develop and implement policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures. Review of sterile filter validations, integrity testing and procedures is also required. The individual is expected to interact with Management, QC and QA leadership. Primary responsibility is to maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products to ensure its meet GMP compliance (EU Annex, 21CFRs, ISO, USP).