Strategic Sourcing Professional (SSSM)

0 - 5 years

4 - 8 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Support supervisor for End-to-end coordination for all projects, interacting with the API vendors and internal teams (Analytical, formulation, Regulatory, QA/QC) to resolve all technical concerns (Documents/analytical issues/material quality) and fulfil requirements for ANDA submission and Regulatory Agency deficiencies, along with Global launch for US and non-regulated markets.
  • Use technical knowledge to perform in-depth review of API drug master file as per current US FDA expectations; identify deficiencies and formulate strategies to resolve them.
  • Close coordination with Packaging material and Excipient vendors, placing orders, arranging technical documents to Analytical and Regulatory teams satisfaction, resolving ARD/QCs technical issues by discussion with Raw material vendors
  • Understanding the impact of changes in Raw material process/specifications and preparation of Change controls and coordinating with internal teams for timely closure
  • Work across multiple time-zones to be in regular contact with global suppliers and cross functional teams within the organization for seamless project management.
  • Routine tracking of all shipment against orders and updating to internal team
  • Actively organize and lead teleconferences with key stakeholders to monitor the progress, identify and resolve key issues for successful execution of projects.
  • Data management for all relevant projects handled within the team
  • Keep up-to-date with the changing market dynamics and FDA regulatory guidelines in the US Generic Industry.

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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