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.
Evaluate industrial environmental regulatory compliance and recommend strategies/practices for ensuring/managing compliance. Conduct environmental compliance audits and recommend corrective actions to ensure compliance with federal, state and local regulations.
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.