Assistant Manager, Quality Assurance - Nitrosamine project
Endo
- Digha, West Bengal
- Permanent
- Full-time
- 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 validation/ verification protocols & reports, SOP’s, Standard Test Procedure & Specification.
- Participate in Investigation of incident, deviation, OOS, and OOT during analysis. QMS trending.
- Timely execution of Assigned Task
- Coordination with Endo/PAR sites for method validation/ verification work.
- M.Sc. Chemistry/M. Pharm with 8-10 years of related experience.