Anton's Answer

Responsible for managing the filling and freeze-drying area annual requalification program, including scheduling, protocol generation, execution, analysis of test results, preparation of summaries, and managing activities assigned to junior personnel. Train new hires. Review and approve protocols and reports prepared by peers. Perform engineering check out, installation, operational, and performance qualification of equipment (sterilizers, freeze-dryers, vacuum verification system, etc.), utilities (WFI, microbial air system), and facilities (cold room, incubator room) in the filling, freeze-drying and packaging area. Perform process qualifications for aseptic processing, lyophilization, and sterilization including design and execution of the studies. Prepare technical reports for submission to regulatory agencies. Present validations to regulatory authorities during inspections. Represent the department on cross-functional project and validation consistency teams. Write new and revise existing SOP's and BPR's. Instituted cGMP compliant method for sterilization validation for the entire site. Work extensively with Kaye (Digistrip and Validator 2000) equipment.