Akanksha Chandel

Work in both the Development and GMP departments, handling analytical developments, wet analysis, and plant investigations in compliance with regulatory standards.

• Perform method development, method validation, and routine analytical testing of raw materials, in-process samples, and finished products.
• Conduct plant investigation work: identifying, analyzing, and resolving problems that occur during manufacturing or testing at the plant.
• Operate, calibrate, and maintain analytical instruments like HPLC, GC, KF, auto-titrator, SOR, and UV-VIS.
• Prepare documentation and investigation reports, ensuring accuracy and compliance with adherence to GMP, GLP, and regulatory compliance.
• Support stability studies, and ensure documentation is in line with GMP.

• Worked in analytical method development department using HPLC and IC instruments.
• Used to calibrate the same system as the one above.
• Gained hands-on experience with troubleshooting instrument issues.
• Conducted forced degradation studies to assess product stability under various stress conditions.
• Executed routine testing as per pharmacopoeial standards.