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 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.
Education & Experience
- M.Sc. Chemistry/M. Pharm with 8-10 years of related experience.
Good hands-on experience in Analysis and Review of, calibration & maintenance of Analytical instruments like LC-MS/MS, LC-MS, GC-MS, GC-MS- Head Space, HPLC, ICPMS, IR, UV, Ion chromatography. GC-FID, GC-ECD.
Commitment To Diversity, Equity, And Inclusion
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
