5+

Write CMC regulatory dossiers for Drug Substance filing (small and Large API Molecules) using source documents, ensuring accuracy, completeness, and compliance.

Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India.

Experience into Literature Survey, Identification of route of synthesis, Process Optimization with respect to cost & quality scale up, Documentation & Characterization.

Downstream processing, TFF system, Buffer preparation; Handling of QMS elements like Change control, Deviation, CAPA, OOS, OOT for downstream process

Handling the Lab instruments of HPLC, Dissolution, D. T., Apparatus, Weighting Balance, Friability, Hardness Tester, FTIR, UV-Spectrophotometer.

Ensure data is transferred for QA audit after QC verification and monitor closure of QA observations within timeline.

Neuland is manufacturer of Active Pharmaceutical Ingredients and provider of Contract Research Services. Neluand has been Preferred Source world wide for APIs and Intermediates for over 25 years.

Review of HPLC/UPLC/GC analytical data; Laboratory investigations, OOS/OOT handling and CAPA management; Change control, deviation management and risk assessment

Cadila Pharmaceuticals is an Indian multinational pharmaceutical company based in Ahmedabad.