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John E. Osani

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John E. Osani, MSQA, CQM, CQA, CQIA, has worked in life sciences (Pharmaceuticals) for 31 years applying his knowledge and expertise to quality systems and compliance develop sustainable regulatory compliance and quality programs within pharmaceutical companies. John has established expertise including, but not limited to: written and organizational skills, GxPs (GMP, GLP, and GDP (Good Distribution Practice and Good Documentation Practice) Consent Decree (CD) verifications; Training/Training Systems; Audit Programs - conducting Internal and Supplier audits for pharmaceuticals- including excipient, API, Contract Lab, and CMOs; Vendor/Supplier Management; Batch Release; Production Floor QA Oversight; Technical Writer for Investigations/Root Cause Analysis (Equipment, Manufacturing, QA (Systems), QC (OOS and EM), and Utilities) ; Change Control and Document Control programs; Validation Support: documentation review (pre and post execution), and execution oversight; CAPA Systems; Documentation (reviewing/Technical Writing of SOPs, batch records, and other documents); and Laboratory Controls. John has established expertise with the following databases/software systems: ComplianceWire, eDocs, EDMS, IsoTrain, ProcessCompliance, and TrackWise. In addition, John has managed quality groups and held an Associate Director-level position in Quality Assurance. He has been the Management Representative for several companies and has dealt with FDA on a number of regulatory visits. John, CQM, CQA, CQIA, has a M.S. in Quality Assurance and a B.S. in Chemistry. He also has achieved a Quality Management Certification from CSUDH. I can be contacted at (424) 205-2343/ and at [email protected] for all future opportunities.

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