Trainee Executive, Technical Procurement

India

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.

Project Coordination : Assisted in managing end-to-end project workflows, including communication with API vendors and internal teams (Analytical, Formulation, Regulatory, QA/QC).
Regulatory Understanding : Familiar with ANDA submission processes and FDA expectations for drug master files.
Technical Documentation : Exposure to reviewing and organizing technical documents for packaging materials, excipients, and raw materials.
Vendor Management : Coordinated with suppliers to resolve technical issues and ensure timely delivery of materials.
Change Control Awareness : Basic understanding of change control processes related to raw material specifications.
Global Communication : Comfortable working across time zones and collaborating with international stakeholders.
Data Management : Maintained project data and tracked shipments to support internal teams.
Meeting Facilitation : Participated in teleconferences to monitor project progress and resolve issues.
Regulatory Trends : Keeps updated with evolving FDA guidelines and market dynamics in the US generic industry.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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