Assay, Related Substances (RS), Chiral Purity, and Residual Solvent Analysis
.
Conduct
method development, method validation, and routine analysis
of raw materials, intermediates, and finished products.
Operate, calibrate, and maintain
HPLC/GC instruments
as per SOPs.
Ensure documentation compliance with
GMP, ICH, USP, EP, JP, and regulatory guidelines
.
Perform troubleshooting and basic maintenance of analytical instruments.
Prepare test reports, COAs, and maintain laboratory records as per
GLP compliance
.
Follow safety and quality standards in laboratory operations.
Collaborate with R&D and Quality Assurance (QA) teams for method validation and transfer activities.