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.
Top Skills
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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