Sumeer Bhargava
Senior Director - Quality Operations @Amneal Pharmaceuticals
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WORK HISTORY
Senior Director - Quality Operations @Amneal Pharmaceuticals
US
As the Senior Director of Quality Operations in the pharmaceutical industry, I oversee a team of 65 dedicated Quality Professionals across various critical areas. Their expertise spans Quality Assurance, Quality Management, Drug Device Compliance (21 CFR 820), Documentation Control, and Inspection Readiness ( 21 CFR 210 and 211 ). My role extends across four distinct locations in Piscataway, New Jersey, each with unique challenges, product focus, and a diverse workforce.In the realm of Transdermal Patches (including Matrix and Hydrogel Systems), I ensure the quality and safety of these specialized drug delivery systems. Simultaneously, I oversee the quality of Topical Products, ranging from creams to ointments, ensuring their compliance. The domain of Complex Solid Dosage and Inhalation Products demands meticulous attention, I safeguard the quality of inhalers and respiratory medications.My leadership transcends geographical boundaries as I spearhead efforts for international expansions, adapting to regional regulations and cultural nuances, I navigate the complexities of global compliance, working closely with external and internal customers across the globe.My days are filled with dynamic responsibilities: leading audits, delving into investigations, addressing customer complaints, managing change controls, facilitating critical decisions through the Quality Review Board, ensuring CFR 820 Compliance, and evolution of our products in Design History Files (DHF).My unwavering commitment to quality lies in ensuring patient safety and supporting Amneal’s vision of providing affordable medicine to all.
EDUCATION
L M College of Pharmacy , Ahmedabad
Masters in Pharmacy, Pharmaceutical Sciences
Institute Of Pharmacy, Amravati University
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
Indian Institute of Management Ahmedabad
Executive Education - Advanced Management Programme , Operations, Finance , and Leadership
SKILLS
ABOUT SUMEER BHARGAVA
Experienced Sr Director Of Quality ( Quality Assurance Operations, Quality Compliance, Data Integrity, Quality Control, Quality Systems and Validation ) with a demonstrated history of working in the pharmaceuticals industry. Skilled in U.S. Food and Drug Administration (FDA), Verification and Validation (V&V), Pharmaceutics, Corrective and Preventive Action (CAPA), and Good Laboratory Practice (GLP). Strong quality assurance professional with a Masters in Pharmacy focused in Pharmaceutical Sciences from L M College of Pharmacy, Ahmedabad.
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