Analytical Development Officer

Role & responsibilities

Impurity Synthesis: Perform the synthesis of organic, inorganic, and Nitrosamine impurities.
Routine Analysis: Execute testing for Assay, Dissolution profiles, Related Substances (RS), GC, IC, and physical parameters.
Method Development: Develop dissolution, Assay, and RS methods, and prepare comprehensive AMD reports and strategy documents.
Qualification & Reviews: Conduct analysis related to API Qualification, DMF reviews, Drug-Excipient compatibility, and Forced Degradation studies.
Compliance & Documentation: Maintain strict GLP/GDP practices, report online results, write/revise SOPs, and ensure audit-readiness for customers and regulatory agencies.
Quality Management: Timely handling of Incidents, Deviations, DCRF, and change controls.
Instrument & Inventory Management: Calibrate analytical instruments, coordinate preventive maintenance/breakdown servicing, and procure project-specific columns, impurities, and chemicals

Preferred candidate profile

Immediate joiners or candidates with a short notice period preferred