Job SummaryMonitors aseptic core to ensure continual compliance with GMP's, Sterility Assurance and provides mentoring on aseptic technique with operators. Reports metrics to team lead on a regular basis.ResponsibilitiesMonitor manufacturing operation by completing daily visual audits of Aseptic Behavior of operators and physical upkeep of aseptic core area. Take immediate action when non- compliance and/or undesired behavior by personnel in the area is observed. Partner with Production/Quality/Training Leadership to make recommendations for enhancements to aseptic process. Communicate openly to operators and supervisors in aseptic core to provide mentoring regarding observed performance. Review aseptic technique associated with media fills Expected to train personnel in Aseptic Techniques and processes Reports metrics and trends to team lead on a regular basis.Skills RequiredIn-depth knowledge and understanding of aseptic techniques, including gowning procedures, material handling, and behaviors within a cleanroom environment. Thorough understanding of Good Manufacturing Practices (GMP) related to aseptic processing and cleanroom operations. Basic understanding of sterility assurance concepts, including contamination control, environmental monitoring, and aseptic process validation. Keen observation skills to conduct visual audits of operator behavior and identify deviations from aseptic procedures. Ability to accurately document observations, non-conformances, and training activities. Ability to effectively train personnel on aseptic techniques and processes. Ability to clearly communicate metrics, trends, and observations to the team lead. High level of attention to detail to identify subtle deviations from aseptic procedures.Qualification: M.Sc (Microbiology / Biotechnology)Experience: 3-5 Years
Job Title
Scientific Officer- Aseptic Process Monitoring (SAG)