Lakshmi Chitrapu

Manager, Quality and Compliance, Compliance Group

With over 13 years of experience in progressively responsible roles within globally regulated companies such as Akorn Pharmaceuticals, Baxter International, Genzyme, and Hospira, I have cultivated strategic leadership skills alongside a deep passion for quality systems. My expertise spans the Pharmaceutical, Medical Device, and Biotechnology sectors, encompassing a comprehensive understanding of cGMP, CFR’s, ISO, ICH, and GAMP guidelines.

Throughout my career, I have spearheaded the development, management, and remediation of quality systems, emphasizing Quality Management Systems (QMS), Quality Compliance, Internal CSV Audit, Data Integrity, Computer Systems Assurance, Corrective and Preventive Action, cGMP Training, Remediation Efforts, Continuous Improvement, and Lean Validation.

I find great truth and value in Benjamin Franklin’s words “Tell me and I forget; Teach me and I remember; Involve me and I learn.” I found these words guided me greatly within Quality and Validation roles, but also influenced my management style.

Outside of work, I enjoy life in Illinois with my husband and two children. Our life adventure has taken more turns and unexpected paths than I had ever imagined, maybe even getting lost a time or two but the journey continues to be amazing, and I love every day of it.

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