1.Expertise in the development, validation and optimization of methods for sterility testing, microbial limit test (MLT), Bacterial Endotoxin Test (BET), In- processes Bioburden and Preservative efficacy test (PET) for newly introduced products.
2. DRL Response in microbiological test for new ANDA Products submission.
3. In-use microbial challenge study of diluent for ANDA.
4. Miscellaneous Protocol based study.
5. Routine calibration of balance, pH & conductivity meter and other daily uses Instruments.
6. Biological indicator challenge test
7. Media Preparation and Processing Growth Promotion Test of Culture Media.
8. Method validation Protocol and summary report preparation.
9 Knowledge In QMS tools
Additional Responsibilities:
Education:
Experience:
Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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