Pharmaceutical Operations Professional with fifteen years of experience in the Biotechnology Pharmaceutical Industry. Excellent knowledge of and experience with processes involved in quality analytical laboratories, validation, manufacturing, quality assurance, process development and distribution. Strong history of contributing to company growth and product launches by implementing continuous process improvement and process optimizations. Ability to lead and motivate high performance teams while maintaining strict quality and regulatory standards. Proven experience in technical writing skills, authoring and reviewing of process investigations technical reports, analytical methods, standard operating procedures (SOP) and protocols. Proficient mnaging SM LIMS, LMES, EBR, SAP, MTR, Maximo (CMMS), CIMS, BTRS, ARMS, EDMQ, Cognos and Trackwise (Deviations, CAPAs and Change Control) quality support systems. Vast knowledge in GMP and GLP regulations and experience in regulatory agencies inspections and audits. Excellent interpersonal and communication skills. Fully bilingual (English and Spanish)
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