John E. Osani's Linkedin Analytics

High-Performing cGMP Consultant / Independent Contractor / Pharmaceutical Quality Professional Overview John Osani is a seasoned cGMP consultant with a wealth of experience in quality assurance and compliance across the pharmaceutical industry. His strategic approach to quality management, coupled with his ability to lead and communicate effectively, ensures that he consistently delivers exceptional results for his clients. With a strong educational background and numerous certifications, John is well-equipped to tackle the most challenging QA and compliance issues, driving continuous improvement and ensuring regulatory adherence. Top Skills and Competencies cGMP, SOPs, Batch Records, Quality Assurance (QA), Quality Management Systems (QMS), Deviation Investigations, Training, Audits, Technical Writing, Active Pharmaceutical Ingredients (API), Supplier Quality, Annual Product Quality Review (APQR), Complaints, Due Diligence, Inspection Readiness, CAPA, Change Control, Pharmaceuticals, Biotechnology, experience using the following software (TrackWise (TW) /EtQ Reliance, Blue Mountain (BMRAM), eDocs/eDMS/ Master Control, SAP, MicroSoft, Teams/Meetings/Zoom, SmartSheet, ComplianceWire/SABA/ Success Factors LMS/ Training Manager), and Proficient in the following regulations: cGMP 111, 210, 211, 600, 601, 610 and 820; ICH (International Council for Harmonisation) Q2, Q6, Q7, Q9, Q10; PICs; EMEA; WHO cGMP; Canada Health, and Taiwan cGMP. I can be contacted at (424) 205-2343/ and at [email protected] for all future opportunities.