Profile Details

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USD 30 /hr

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Hire Sunita V.

India

USD 30 /hr

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

Profile Summary

• 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

Subject Matter Expertise

• ☆ 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

Services

• Writing
• Product Development

Writing Medical Writing, Technical Writing

Product Development Formulation, Stability/Shelf Life Testing

Work Experience

Jubilant Life Sciences (India)

- Present

Research Associate

Jubilant Generics, Noida

December 2018 - July 2021

Education

M. Pharm (Pharmaceutical Chemistry)

RTM Nagpur University

July 2014 - August 2016

Certifications

• NA

  NA

  January 2025 - January 2025