Sr. Global Consultant Associate with broad background in auditing, project development and risk management. Developed the GxP approach to proactively improve the Quality Management Systems of Audits for the following functional groups: Pharmacovigilance, Regulatory, Medical and GMP Product Quality in order to identify problems not visible when processes are looked in a fragmented way versus holistically. Integrated auditing and compliance systems across all GxP areas including designing audits and compliance practices which ensure early detection, analysis and reporting of compliance signals to effect change within the enterprise. Established and executed audits using risk based prioritization ensuring continued compliance with global regulations and standards.
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