Senior Executive, Technical Procurement

Amneal Pharmaceuticals -
Ahmedabad, Gujarat

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Job details

Full-time
9 days ago

Qualifications

B.Sc
Master's degree
Bachelor's degree
APIs
Business Administration
MBA
FDA regulations

Full job description

Key Responsibilities

Project Coordination
- Support supervisor in managing end-to-end coordination for all US, EU projects.
- Interact with vendors and internal teams (Analytical, Formulation, Regulatory, QA/QC) to resolve technical concerns (documents, analytical issues, material quality).
- Ensure requirements are met for regulatory submissions and regulatory agency deficiencies with respect to Raw material / packaging material.
Vendor & Material Management
- Support vendor qualification activities including technical questionnaires, DMF gap assessments, and follow-ups where applicable.
- Arrange technical documents to R&D team requirements.
- Resolve ARD/QC technical issues, Regulatory & Quality requirement by liaising with raw material vendors.
- Handle complaints related to raw material quality in coordination with QA and vendors.
- Prepare, update, and maintain centralized technical procurement databases (vendor details, material specifications, regulatory status, change history, risk assessments).
- Understand the impact of changes in raw material processes/specifications, prepare change controls, and coordinate with internal teams for timely closure.
Commercial & Logistics Support
- Prepare purchase orders and coordinate with logistics for inwarding concerns.
- Track shipments against orders and update internal teams routinely.
- Coordinate with finance for pending payments against orders.
- Manage order processing of API, excipients, impurities, and reference standards, ensuring timely delivery.
- Support responses to regulatory queries/deficiencies related to raw and packaging materials under guidance of Regulatory Affairs
Compliance & Continuous Learning
- Stay updated with ICH guidelines and FDA requirements.
- Present key regulatory updates internally on a routine basis.

Key Competencies

Technical Knowledge : Strong understanding of pharmaceutical raw materials, packaging, and regulatory requirements (FDA, ICH).
Coordination & Communication : Excellent ability to liaise with multiple stakeholders, both internal and external, ensuring clarity and timely resolution.
Problem-Solving : Proactive in identifying issues and driving effective solutions with vendors and internal teams.
Adaptability : Quick learner with the ability to grasp technical concepts and adjust to evolving regulatory requirements with aptitude to manage multiple projects simultaneously.
Reliability & Integrity : Demonstrates diligence, dependability, and professional conduct in all responsibilities.

Education:

Bachelors Degree (BA/BS) BA - Required

Master Degree (MBA) MBA - Preferred

Experience:

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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