Ensuring compliance success of a fast growing client importer organization with a unique portfolio of branded Drugs and NHP products. Managing importer quality systems, customer complaint investigations, providing internal GMP training, change controls, deviations, CAPAs, conducting audits of contract manufacturers, laboratories and logistics providers.

Ensured compliance to importer and distributor GMP requirements across a wide range of products and clients through batch disposition, deviation reporting & investigation, CAPA, monitoring of stability programs, and completion of annual GMP compliance activities.Provided on-site GMP-consulting services to an Importer and Market Authorization Holder organization.Monitored and approved customer complaint investigationsAudited warehouse third-party logistics providersAudited a… Show more Ensured compliance to importer and distributor GMP requirements across a wide range of products and clients through batch disposition, deviation reporting & investigation, CAPA, monitoring of stability programs, and completion of annual GMP compliance activities.Provided on-site GMP-consulting services to an Importer and Market Authorization Holder organization.Monitored and approved customer complaint investigationsAudited warehouse third-party logistics providersAudited a radio-pharmaceutical manufacturing facility Show less

Ensured compliance of contract-manufactured products through product change management and documentation review as part of batch release while delivering on Quality and Compliance objectives to support business-critical initiatives related to mergers, acquisitions, site closures, product launches and transformations of quality systems and quality units.