Senior Officer / Executive - Technology Transfer
Amneal Pharmaceuticals LLC
Ahmedabad, Gujarat, India
Posted on 14-02-2022
1 Vacancy
Description
- Responsible for co-ordination with cross functional departments for execution of scale-up / feasibility batches, Exhibit batches and ANDA submission.
- Responsible for execution of scale-up / feasibility, Exhibit batches for regulatory submissions.
- Responsible for review of Technology transfer documents for Exhibit batches.
- 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.
- Responsible for preparation / review of master documents like BMR (Batch manufacturing record) & BPR (Batch Packing record) for Exhibit / intended commercial batches.
- 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.
Category
Pharmaceuticals
Functional Area
Process Engineering
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