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Executive-SSSM

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

3 - 7 years

4 - 8 Lacs

Ahmedabad

Posted:3 months ago| Platform:

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Skills Required

QC Data management Anda Project management Analytical Packaging Raw material Project handling Technical documentation

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Work from Office

Job Type

Full Time

Job Description

Key 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 team s satisfaction, resolving ARD/QC s 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 COMPANY (INDIA) PRIVATE LIMITED

www.amneal.com

Pharmaceutical Manufacturing

Bridgewater New Jersey

5001-10000 Employees

23 Jobs

Key People

Chirag Patel

Co-CEO
Shyam Patel

Co-CEO
Jeffrey T. Arokiasamy

Senior Vice President of Business Development

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Executive-SSSM

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Skills Required

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Executive-SSSM

Experience & Salary

Skills Required

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Job Description

More Jobs at AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

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