Senior Formulation Operations Specialist

2 days ago


Navi Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time

USV PRIVATE LIMITED is seeking a highly skilled Senior Formulation Operations Specialist to join our team. As a key member of our formulation operations department, you will play a crucial role in ensuring the smooth execution of various batches, including pilot lab, assessment, and commercial launch validation batches.

The successful candidate will have strong technical knowledge related to pre-filled syringes, cartridges, design history files, and pen devices. Key responsibilities will include facilitating pilot BE batches at our Govandi pilot lab, monitoring environmental control, planning and executing scale-up/optimization batches, and ensuring availability of lab consumables and equipment AMCs.

In addition, the Senior Formulation Operations Specialist will be responsible for assessing batches, calculating batch sizes, initiating procurement and tracking receipt of raw materials, preparing process QRA documents, providing inputs to documentation teams, and executing assessment batches.

The ideal candidate will also participate in planning exhibit/submission batches, calculate batch sizes according to regulatory requirements, check availability and release of API, RM, and documents, review required documents, execute exhibit/submission batches, provide support and contribute in investigations for any OOS observations, and provide timely feedback and updates to Team Leaders.

We are offering a competitive salary range of ₹12-18 lakhs per annum based on location and experience.



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