Amit Kumar

About Amit Kumar

Quality professional with 6+ years of experience in QC, QA, and Compliance within regulated pharmaceutical environments, with strong expertise in inhalation dosage forms (MDI/DPI).Currently working as a Senior Executive at Aurobindo Pharma, supporting QC/QA and compliance activities across multiple US sites, including Change Control, Deviations, CAPA, OOS/OOT investigations, complaints, trend analysis, and inspection readiness. Experienced in document review and approval, analytical method validation and transfer, process validation, and technology transfer documentation.Hands-on experience in data integrity, audit trail review, and electronic data review/sign-off using Empower, LIMS, and standalone systems, along with responsibilities as a LIMS Administrator/Author.Previously at Glenmark, Abbott, and Cipla, gained strong exposure to stability studies, analytical testing, and QMS activities for MDI/DPI products, performing tests such as UODD, FPD, Assay, RS, CU, KF, UV, and IR.Focused on regulatory compliance, data integrity, and continuous improvement, with interest in Quality Compliance, QA Operations, and Global Quality roles.

Experience

1. Senior Executive

   Aurobindo Pharma Ltd

   Sep 2025 — Present · Hyderabad, IN

   Support Quality (QC/QA) and Compliance activities across multiple US sites in alignment with global quality systems and regulatory requirements.Review and manage Quality System elements including Change Control, Deviations, CAPA, OOS/OOT investigations, complaints, and trend analysis.Review and approve controlled documents such as testing procedures, validation protocols/reports, analytical method validation and transfer, process validation, and technology transfer documentation.Perform audit trail review, data integrity checks, and electronic chromatographic data review/sign-off (Empower, LIMS, standalone systems).Act as LIMS Administrator/Author, managing specifications, tests, worksheets, sample types, COAs, working standards, and validation samples.Support implementation of global procedures, system upgrades, and new quality applications at site level.Lead and support change control activities related to specifications, STPs, and laboratory systems.Contribute to protocol preparation, impact and gap assessments, risk evaluations, and inspection readiness activities.

Education

• Dr. S.S. Bhatnagar UICET, Panjab University

  Master's degree, industrial chemistry

  2017 — 2019

• Maharshi Dayanand University

  Bachelor's degree, Chemistry

  2013 — 2016

• A. V. M sr. sec. school, ballabgarh, Faridabad

  12, Science

  2011 — 2012