Jyoti Mahajan

Jyoti Mahajan is a Regulatory and Quality Management professional having20 years of rich & diversified experience in different spheres of Vaccine and Biological Industry.

She has a thorough understanding of unique individual demands of the industry and ability to fulfil its exceptional needs.

She is proficient in designing, streamlining and implementation of processes to facilitate robust Quality Management System and implementation of GMP. Her expertise lies in performing Risk Assessments, Gap analysis, Investigations and Root cause analysis. She is highly competent in handling various QMS tools including incidents, deviations, change controls, CAPA, validations, documentation & training.

She has rich experience in managing the spectrum of regulatory activities and dossier preparation.

During her career with leading vaccine industry, she played a key role in the WHO pre-qualification process for various vaccines. She spearhead many Quality Audits and also prepared & supported organization during various cGMP and regulatory audits.