Poonam Malave

Background

About Poonam Malave

Dynamic Quality Control & Project Management Expert | FDA-Regulated Pharmaceutical Manufacturing | Cross-Functional Leadership | Validation & Compliance Specialist. I am a results-driven professional with extensive experience in quality control within FDA-regulated pharmaceutical and aseptic manufacturing environments. My expertise lies in test method validation, container closure integrity testing, and risk assessments, where I have consistently delivered high-quality results. As a seasoned project manager, I excel in leading cross-functional teams to drive product launches across North America, LATAM, EU, and Asia. My leadership skills are complemented by a deep technical knowledge that ensures compliance with FDA standards, particularly during audits and in authoring regulatory submissions, including CTD sections and response writing. My experience also includes creating and managing annual budgets for equipment, testing materials, and FTE resource headcount. I am adept at conducting validation studies for disinfectant efficiency in ISO 5, 7, and 8 classified clean rooms and proficient in microbial identification using Micro Seq, Vitek, and Biolog systems. I am passionate about advancing quality and compliance in the pharmaceutical industry and continuously seek opportunities to leverage my skills to drive organizational success. Publication, http://dx.doi.org/10.1016/j.foodchem.2015.08.024