Key Responsibilities
- Perform
Method Development (MMD)
and
Method Validation (MV)
for OSD formulations as per ICH guidelines.
- Support
Build-Up (BU)
batches and analytical activities during formulation/product development.
- Conduct
Dissolution Method Development
and routine dissolution testing.
- Perform
Forced Degradation (FD)
studies to establish stability-indicating analytical methods.
- Handle analytical instruments such as
HPLC, UPLC, UV-Visible Spectrophotometer, Dissolution Apparatus, and KF Titrator
.
- Prepare and review analytical protocols, validation reports, SOPs, specifications, and laboratory documentation.
- Ensure compliance with
ICH Guidelines, cGMP, GLP, Data Integrity, and regulatory requirements
.
- Support analytical troubleshooting and cross-functional product development activities.