Responsible for Preparation of Master BMR, BPRs and document management.
Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
Responsible for reviewing GMP related documents.
Responsible to select Equipment at Facility.
To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes.
To study critical parameters during scale up batches to optimize the CPPs and CQAs.
To provide the input related to batch size, process feasibility & process parameters to formulation scientist as per requirement.
To monitor and ensure readiness for execution of scale-up / feasibility batches, Exhibit batches with respect to RM, PM & Miscellaneous items.
Responsible for reviewing GMP related documents as applicable.
To get actively involve in Scale-up and Exhibit batches.
M. Pharm
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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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