Assistant Manager, Quality Assurance - Nitrosamine project

Updated: April 18, 2024 12:47 PM GMT

Endo International plc

Ghatshila, Jharkhand

Job Description Summary

This role entails the responsibility of conducting comprehensive Nitrosamine studies for Endo India, contributing to our commitment to ensuring product safety and compliance with global regulatory standards

Job Description
• Sound Knowledge on guidelines of Nitrosamine impurity.
• Responsible for review of Nitrosamine study data for Endo/ PAR sites.
• Good technical knowledge on data review for finished product/stability/Raw material samples and analytical method validation/verification study related to nitrosamine impurities.
• Sound technical knowledge on review of Qualification, calibration & maintenance of Analytical instruments like LC-Ms, LC-MS, GC-MS, GC-MS- Head Space, GC-FID, GC-ECD etc.
• Having good technical knowledge of quality management system (Change control, CAPA, Incidents, OOS, OOT)
• Responsible to support various regulatory inspections and compliance report preparation.
• Preparation and Review of SOP, laboratory documents like method... More Detail