- Supervise the workflow in sterile and non-sterile compounding areas, including training and tracking compliance of employees.
- Develop competency assessments and ensure compliance with training requirements
- Direct day-to-day aseptic preparation operations in cleanrooms, ensuring safe, efficient, and timely delivery of sterile compounds.
- Assume responsibility for all activities within the cleanroom during preparation sessions, adhering to Standard Operating Procedures (SOP).
- Monitor cleanroom workflow and assign staff duties accordingly.
- Oversees the Quality Management Program related to compounding, including surface sampling, microbial growth trends, and hood certifications.
- Track and analyze cleaning activities, temperature, and humidity monitoring in clean areas.
- Manage technology updates and changes in workflow systems.
- Ensure adherence to compounding SOPs and review/update policies as necessary.
- Stay informed about regulatory changes and implement necessary updates.
- Serve as the designated person for USP 795, 797 and 800.
- Oversee investigational drug studies.
|
