In this role, the selected candidate will prepare clear, detailed and accurate compliance documentation, including narratives, control descriptions, risk control matrices, test programs, and performance metrics.
Provide insight and individual contribution in obtaining and maintaining compliance with ICH Q7 guidance for active pharmaceutical ingredients. Troubleshoot method and process issues in assurance of successful validation. Recommend technical design/changes to improve efficiency, quality or performance in support of validation.
Coordinate reviews of SOD conflicts for the applications in scope, accordingly to the calendar defined by process & tools team;· participate on GA Compliance monthly communication board and also on SOX Steering Committee.
Develops, implements and maintains an appropriate level of operating procedures, policies and standards necessary to support the standardization of regulatory compliance among Zebras centers of excellence.