Expertise in,

- Expertise in analytical method validation for injectable products, including assay, related substances, content estimation, molecular weight determination, CCIT, particle size distribution, zeta potential, and cleaning validation.

- Experience in forced degradation studies, analytical method transfer (AMT) and analytical method equivalency (AME).

- Hands-on experience with instruments such as HPLC, UPLC, GC, UV, KF/coulometer, autotitrator, zeta sizer, Mastersizer, USP Type-I, II and IV.

Core expertise

- Lead analytical validation (AMV), transfer (AMT), and equivalency (AME) studies for injectable products, including assay, related substances, content estimation, molecular weight determination, CCIT, Particle size distribution, zeta potential, and cleaning validation.

- Prepare test data sheets, protocols,



and reports for AMV, AMT and AME studies.

- Conduct analytical method feasibility studies for injectable product tests such as assay, related substances, preservative content, molecular weight, and cleaning methods.

- Support injectable projects by addressing analytical queries and related activities.

- Operate and calibrate analytical instruments.

- Carry out daily analytical laboratory activities in compliance with GLP/GMP guidelines.

- Maintain the work area in accordance with GLP, GMP, and safety guidelines.

Work Experience

4 to 6 years

Education

Masters in Pharmacy or Science

Competencies

📌 Research Associate : Pharma Research Injectable (India)
🏢 LUPIN
📍 India