Assistant Manager - R&D Raw Material Purchase

Sahaj Pharma

7 - 15 years

7 - 9 Lacs

mumbai

Posted:1 week ago| Platform:

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Skills Required

raw material procurement cda raw material purchase purchase raw material procurement foc excipients

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities :

To ensure timely sourcing of API and key excipients for US, EU, CA, ROW , WHO , Domestic, China (as per requirement )
To prepare checklist required for PIF generation
To prepare business case for project feasibility analysis
To update sourcing Tracker for pricing and regulatory updates
To arrange FOC samples required as per development need
To process CDA and keep track record for all raw materials
To arrange DMF at all milestones (ED,EB, NPL)
To arrange all supply agreements for API and key raw materials
To co-ordinate with internal and external stake holders
To obtain Regulatory query responses /documents
To perform benchmarking and keep tracker updated for NPL projects
To arrange deliveries for critical projects
To track and maintain a tracker for all submission related docs for dossier submission for all markets.
To provide and keep track of AMD, ARD, PDR technical concerns where documentation support needed (stability data, MOA, trend data, NItrosamine report for API's and category excipients)
To Support the function for maintaining SLA (daily task) tracker to understand gaps and improve the performance level.

Job Requirements :

Strong understanding of Certificate of Analysis procedures for raw materials.
Knowledge of excipients used in pharmaceutical API is essential.
Experience in purchasing, procurement, or raw material management.
Ability to negotiate with vendors and conduct market research.
Strong analytical and problem-solving skills.
Familiarity with FOC, CDA, and other relevant regulations.

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