Y.V.S. PAVAN KUMAR

• Lead end-to-end manufacturing operations, overseeing production planning, execution, and compliance across multiple blocks.
• Preparation of monthly production schedules based on the business requirements of intermediates, as well as APIs, with the coordination of the business planning team.
• Monitor the smooth running of production activity, and meet the dispatch targets.
• Following cGMP, housekeeping, and giving training to new and shop floor employees.
• Follow preventive maintenance as per schedule, and check the performance of all equipment. Following the safety procedures and appliances to avoid incidents.
• Troubleshooting process problems and reviewing with team members for the implementation of process and yield improvement, and time cycle reduction.
• Spearheaded implementation of advanced automation systems, including LMS and DocHub, for digital transformation.
• Maintain the production area with zero safety incidents.
• Qualified new peptide production block with cutting-edge equipment (lyophilizer). Performed successful completion of global regulatory audits (USFDA, PMDA, MHRA, EDQM, COFEPRIS, SFDA, Health Canada) with zero critical observations. Played a key role in harmonizing quality systems and procedures, supporting DMF submissions.
• Managed tech transfer and documentation for Kilo lab and NPD molecules, including BPRs, equipment cleaning records, and validation protocols (trial, commercial, and R&D-supported).
• Mentored cross-functional teams, and served as a certified GMP trainer and ISO 27001:2005 internal auditor.
• Supported over 50 customer audits, including GSK, Merck, Abbott, and AstraZeneca.

Production Leadership:

Headed the qualification of a new peptide production block, implementing advanced systems including a lyophilizer, dry heat sterilization, and isolators, along with different capacities of reactors and other equipment.

Conducting daily LDM and conducting shop floor training on SOPs,

Quality Systems, and Training.

Executed RCA and CAPA processes, reviewed change controls, and deviations.

Delivered cGMP training, evaluated personnel qualifications, and optimized team performance.

🔧 PROFICIENCY FORTE

• Peptide Manufacturing Expertise: Specialized in peptide products and instrumentation, including automated peptide synthesis, lyophilization.
• Automation Implementation: Hands-on experience with DCS, MES, LMS, and DocHub for digitizing and optimizing production workflows.
• Technology Transfer: Active involvement in transferring new products from CPS and NPD into commercial manufacturing.
• Equipment & Personnel Qualification: Experienced in drafting and executing URS, IQ, OQ, and PQ protocols for equipment and personnel.
• Change Management: Performed change control processes, ensuring pre- and post-change compliance, timely implementation, and closure per SOP guidelines.
• Quality Systems: Strong command of failure investigations, RCA, and CAPA lifecycle management, QMS, and SOPs.

🏆 PROFESSIONAL ACCOMPLISHMENTS:

Regulatory Audits and Compliance:

• Successfully cleared USFDA audits (2011, 2017, 2023) with zero 483s.
• Achieved zero observations in GMP audits by COFEPRIS (Mexico), SFDA (China), EDQM, PMDA, and Health Canada. Supported 50+ global customer audits (GSK, Merck, Abbott, AstraZeneca, etc.).
• Maintained zero overdue CAPAs, and introduced a simplified CAPA system to enhance compliance.