Rajendra Prasad Yadav: Difference between revisions
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==Education== | ==Education== | ||
He holds a Master of Science degree in Organic Chemistry. Additionally, he is certified in Nutrition Management, Training Management, and Sports Supplement Management. | He holds a Master of Science degree in Organic Chemistry. Additionally, he is certified in Nutrition Management, Training Management, and Sports Supplement Management. | ||
He is also certified as a Six Sigma Black Belt and Six Sigma Yellow Belt, demonstrating expertise in process improvement and quality methodologies. | |||
==Professional Certifications & Expertise== | |||
Rajendra Prasad Yadav is a highly accomplished quality professional with an extensive portfolio of certifications that reflect his deep expertise in quality systems, regulatory compliance, and continuous improvement within the pharmaceutical and life sciences industry. | |||
He holds a Six Sigma Black Belt and Six Sigma Yellow Belt, demonstrating advanced proficiency in process optimization, statistical analysis, and operational excellence. | |||
His specialization in quality and compliance includes certifications in Quality Management Systems, Quality Risk Management, and cGMP, equipping him with a strong understanding of global regulatory expectations and pharmaceutical quality frameworks. | |||
He is certified in Investigation and CAPA Management, enabling him to lead complex investigations and implement corrective and preventive actions aligned with regulatory standards. | |||
He also holds certification in Measurement Uncertainty (ISO/IEC 17043) and is trained as an Internal Auditor for Laboratory Management Systems (ISO/IEC 17025:2017), demonstrating expertise in laboratory quality systems and compliance. | |||
Additionally, he holds Food Safety Supervisor Competency certification (FOSTAC – Advance Level 2), expanding his expertise into food safety and regulatory compliance. | |||
He has received State FDA approval in Quality Control Analysis covering chemical, instrumental, and microbiological domains, validating his technical expertise across analytical platforms. | |||
These certifications collectively reflect his commitment to quality excellence, regulatory compliance, and continuous improvement in pharmaceutical operations. | |||
==Career== | ==Career== | ||
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He has a proven track record as a remediation expert, leading investigations, CAPA effectiveness, and product/process robustness programs across multiple sites. Rajendra has extensive experience handling global regulatory inspections and compliance frameworks including USFDA (21 CFR Part 210/211), EU GMP, MHRA, TGA, Health Canada, ANVISA, PMDA, WHO, and PIC/S. | He has a proven track record as a remediation expert, leading investigations, CAPA effectiveness, and product/process robustness programs across multiple sites. Rajendra has extensive experience handling global regulatory inspections and compliance frameworks including USFDA (21 CFR Part 210/211), EU GMP, MHRA, TGA, Health Canada, ANVISA, PMDA, WHO, and PIC/S. | ||
His leadership roles include Head – Quality & Compliance at Jubilant Lifesciences, Senior GM & Head – Quality at Refex Group – RLFC, and senior positions at Sun Pharma, Ranbaxy, Cipla, Zydus Cadila, and Ipca. He has led multiple successful regulatory inspections and audit readiness programs with a focus on an | His leadership roles include Head – Quality & Compliance at Jubilant Lifesciences, Senior GM & Head – Quality at Refex Group – RLFC, and senior positions at Sun Pharma, Ranbaxy, Cipla, Zydus Cadila, and Ipca. He has led multiple successful regulatory inspections and audit readiness programs with a focus on an all-time inspection readiness model, closure of systemic gaps, and board-level compliance reporting. | ||
Rajendra has driven digital quality systems implementation and transformation, leading Trackwise Phase 2 Go-Live and managing LIMS, SAP (HANA), EDMS, Trackwise, and GQS. He also led regulatory strategy and commercialization for new facilities, managed change controls, process validation strategies, and global filing readiness for US, EU, and UK markets. | |||
He has expertise in data integrity, audit trail governance, deviation investigations, process validation, supplier qualification, stability programs, and regulatory submissions. | |||
He has successfully collaborated with global stakeholders such as Navinta LLC, Waymade, Everstone, EY/Parthenon, Honeywell, and ACG, leading cross-functional teams for quality transformation and business continuity. | |||
Rajendra is recognized for building high-performance, accountable quality teams, driving quality culture transformation, and delivering business continuity with compliance under aggressive timelines. | |||
==Personal Life== | ==Personal Life== | ||
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==External Links== | ==External Links== | ||
* [https://www.linkedin.com/in/rajendra-y?utm_source=share_via&utm_content=profile&utm_medium=member_ios LinkedIn - @rajendra-y] | * [https://www.linkedin.com/in/rajendra-y?utm_source=share_via&utm_content=profile&utm_medium=member_ios LinkedIn - @rajendra-y] | ||