Senior Officer / Executive - Technology Transfer

Senior Officer / Executive - Technology Transfer

work outline icon2 - 6 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Amneal Pharmaceuticals LLC

time outline iconAhmedabad, 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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