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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES



Robert J. Serra
Process Development/Validation

Schering Plough, Inc. - Global Manager Technology Transfer

Ortho Biotech - PSGA - cGMP Compliance

Novartis Pharmaceutical - Process Validation

Johnson & Johnson - RWJ Research - Process Development & cGMP Compliance

Ethicon, Inc. - Management - cGMP Compliance & Quality Laboratory

Academic Achievements

Chemistry B.S. - Fairleigh Dickinson University

Systems Engineer Graduate Work - Fairleigh Dickinson University

ISO 9000 Lead Auditor Certification

6-Sigma Certified Black Belt