Manoj Gera

High impact professional with a proven track record of delivering complex technical projects across the entire Pharma Manufacturing Lifecycle. Experienced in building & managing self-driven teams. A team player dedicated to both the personal and organization growth. Having over 13 years of experience in the area/s of Equipment & Facility Qualification Lifecycle Management (CQV), Technology Transfer, Process Validation, Risk Assessments (dFMEA, pFMEA, Cleaning FMEAs, Facility RA), CSV, Potent Product Assessments, PAC Assessments, Audit and Compliance (Consent Decree & Warning Letter Remediation), Human Error Reduction & Batch Record Simplification, Process Excellence and Digitalization. Started career with Ranbaxy and subsequently with Sun Pharma, Sandoz Pvt. Ltd. At present, he is responsible for the Quality Risk Management and CQV operations of Zydus Lifesciences Ltd. Experienced in addressing regulatory inspection findings & their ongoing compliance program, consent decree remediation and with implementing CAPA plans to prevent re-occurrence. Completed bachelor's in Pharmaceuticals and Master’s in Pharmaceutics from Punjabi University, India where he published multiple papers across reputed peer-reviewed journals. Regularly contributes to presentations and workshops for standard-setting organizations: PDA (Parenteral Drug Association) India Chapter for “Cleaning & Its Risks” and IPA (Indian Pharmaceutical Alliance) for “Human Error Investigation”.