プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Sunita V.に依頼

India

Experience in Analytical Development, Quality Assurance, and Regulatory Affairs. Skilled in method validation

プロフィール概要

• Regulatory Documentation – CTD/eCTD, ANDA/NDA filing, Regulatory submissions (US, EU, ROW) • Quality Assurance – GMP, GLP, ICH Guidelines, Audit readiness, CAPA management, Deviation, OOS, OOT handing • Analytical Techniques – HPLC (Waters), UV Spectrophotometer (Shimadzu), Dissolution Apparatus • Pharma Documentation – SOP preparation, Stability data preparation, Analytical Test Procedures • Software – LIMS, TrackWise • Exhibit Batches – Release, Testing, and Report preparation • Team collaboration and cross-functional coordination

専門分野

• ☆ Analytical Chemistry
• ☆ Spectrophotometry
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Drug Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Concept Development
• ☆ Skills Training

サービス

• Writing
• Product Development

Writing Medical Writing, Technical Writing

Product Development Formulation, Stability/Shelf Life Testing

職務経験

Jubilant Life Sciences (India)

- 現在

Research Associate

Jubilant Generics, Noida

12月 2018 - 7月 2021

学歴

M. Pharm (Pharmaceutical Chemistry)

RTM Nagpur University

7月 2014 - 8月 2016

認定資格

• NA

  NA

  1月 2025 - 1月 2025