IRA ROW - Moraiya Plant

Zydus Group

2 years

1 - 4 Lacs

ahmedabad

Posted:1 day ago| Platform: GlassDoor logo

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Skills Required

development report stability data updating validator dispatch

Work Mode

On-site

Job Type

Part Time

Job Description

Division

IRA

Job posted on

Oct 30, 2025

Employee Type

P-P8-Probationer-HO Executive

Experience range (Years)

2 years - 5 years

Review of Technical Documents (EDMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.)

Compilation and review of dossiers as per requirements for Countries.
Compilation of deficiency responses of new product submission.
To prepare and submit the variation for post approval changes.
To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation.
To prepare and maintain various registration Data base & updating at Central Depository
Compilation and Review of commercial and supporting documents
To Review and Approve Change Control Activity- Action item Closure in Track wise System.
To Review and Approve PVP-PVSR in Validator System.
To Compile APQR for Moraiya Plant every Month.
To Dispatch Samples according to filing Plan when required by Regulatory Markets
To arrange documents for Deficiency response, Dossier filing, Tender Business and renewal Dossier filing on time. (Plants- Moraiya- SEZ-Biologics-Topical-ZRC-LL)
To do timely Signing for all documents generated from PTC and Other plants as mentioned above.
Maintaining Sample Sheet for various markets as defined as per Dossier filing plan.

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