Sterility Assurance

Job description

**Key Responsibilities** 1. Oversight of aseptic area and isolator-based aseptic processing and sterility assurance program. 2. To perform oversight activity during routine production 3. Prepare and review of Aseptic Process Simulation (Media Fill) protocols and reports. 4. Assessment of aseptic interventions. 5. Review of environmental monitoring (viable, non-viable) and trend analysis. 6. Participation in deviation investigations, CAPA, and risk assessments. 7. Prepare and review of CCS (contamination control strategies) 8. Review of smoke study protocol, report and video recording. 9. Review of microbial data deviation 10. Review of executed Aseptic process simulation study (Media fill) BMR. 11. Support regulatory audits and act as sterility assurance SME. 12. Ensure compliance with EU GMP Annex 1, US FDA, and WHO GMP requirements. 13. To participate the regulatory or any external inspection at site. **Experience** experience in sterile pharmaceutical manufacturing. Hands-on experience with isolator systems, media fills, smoke study and environmental monitoring. **Skills and Competencies** Strong knowledge of aseptic processing, smoke study and contamination control. Good understanding of regulatory requirements and data integrity. Strong investigation and root cause analysis skills.