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He/She will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and
Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests,
Supervise Daily Laboratory operations, ensuring personnel execute their responsibilities in strict accordance with relevant regulatory guidelines. Support the weekly and daily production schedules and participate in the daily Tier 1 & 2 meeting