Milindkumar Rajput

About Milindkumar Rajput

With over 14 years of analytical experience in a USFDA approved pharmaceutical company, I possess complete knowledge of the analytical skills required for method development, method validation, release testing, characterization, API, excipients, stability, and troubleshooting. My skills include Six Sigma Yellow Belt, Quality by Design (QbD), cGMP, Design of Experiment (DoE), cGMP Quality Improvement, risk management process and analysis, innovation, QMS, GDP, and LIMS.I have excellent knowledge of cGMP, cGLP, ICH, and FDA guidelines. My responsibilities include supporting formulation development to file ANDAs in-time, studying the in-vitro dissolution profiles of the development samples, deformulation studies, product development and optimization studies, and accelerated stability studies. I am proficient in performing analysis using HPLC, GC, UV-Vis Spectrophotometer, Auto Titrator, PSD (Malvern), FTIR, dissolution & IV), KF, polarimeter, stability chambers & wet chemistry analysis, as well as lab software\'s like Empower and LIMS.I am responsible for addressing OOS (Out of Specifications), laboratory incidents (quality impacting as well as non-impacting), deviations, writing and updating SOP\'s and analytical test methods, and finalizing specifications. My expertise lies in ensuring compliance with quality and safety related SOPs.

Experience

1. Scientist

   Brill Pharma

   Jul 2023 — Present · Mumbai, IN

Education

• Bharati Vidyapeeth

  M.PHARM

  2009 — 2011

• Bharati Vidyapeeth

  Bachelor of Pharmacy - BPharm

  2005 — 2009

Skills

• Gmp
• Uv/Vis
• Drug Delivery
• Pharmaceutical Industry
• Sop
• Fda
• Technology Transfer
• Hplc
• Dissolution
• Validation
• Pharmaceutics
• Glp
• Formulation