Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting.
Prepare and compile DMFs in compliance with regulations for regulatory and semi-regulatory countries. Provide necessary documentation support to the Marketing department.
We have a specialized R&D facility in Chennai as well as top-notch manufacturing operations in India. In Chennai, there is a specialized OSD research and FRD at Chennai
Having good knowledge of Granulation Machines, Compression Machine and Coating process. Should have exposure to handling of Validation and Qualification procedures. Knowledge of handling SAP activities.
USV Private Limited is an Indian multinational pharmaceutical and biotechnology company in Mumbai. The company operates across 75 countries globally, and is a leading producer of Metformin in India.
Candidates should have hands on experience along with knowledge of 21 CFR compliance in equipment's like RMG, FBE, V-Blender, Fette compression machine, Auto coater, CVC Line and packaging line equipment with Track and Trace system.
Monitor Cleaning of Reactor, Centrifuge, ANFD, Filtration System, Dryer, Miller, Sifter and Micronizer as per approved cleaning Records, SOPs. Execution of batch operations like material charging, extractions, workups, filtration, additions, centrifuging, drying, sampling and labelling.
Having Injectable Experience of Shop floor Supervising activities like Aseptic Filling, Shop Floor Supervising activities and PFS. Pre Filled Syringe Experienced Candidates Highly Preferable.