Manufacturing Compliance Program Manager
Current1) Monitors, communicates and facilitates compliance timelines for the Manufacturing Department: -Corrective Action/Preventive Action progress, Extensions/Interim reports and closure -CAPA Effectiveness Check closure -Change Control progress for deliverables, extensions and closure -Change Control Effectiveness Check Closures -Periodic Review for SOP’s -Closure of Calibration Alert Notifications (CAN’s) -Change Control Closure to meet QA disposition timelines 2) Collaborate with Quality Assurance and other departments to accomplish compliance and closure timelines. 3) Organize Collaboration meetings to resolve or expedite Quality events to ensure compliance. 4) Complie and track monthly manufacturing room audits for departments: Upstream, Downstream and Support groups