Pune_RD Research Associate Pharma Research Injectable MH
Pune, IndiaEntry · 0-2 years
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About this role
Job Description
Expertise in,
Expertise in analytical method development and 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, and zeta sizer.
Core expertise
Lead analytical method development, 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 development and 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.
Perform routine and stability sample analysis for injectable products.
Evaluate excipients used in injectable products.
Carry out daily analytical laboratory activities in compliance with GLP/GMP guidelines.
Maintain the work area in accordance with GLP, GMP, and safety guidelines.
