Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally.
Walk-in to meet us on Saturday, December 18, [email protected] Taloja R&D Centre.
Experience : 3 to 15years
Qualification : M. Pharm/ M.Sc
Roles and Responsibilities :
The compilation of ANDAs, and ensure for timely submission to USFDA. Preferred for Solidoral / Topical / Gel.
The assessment for outsourced DMFs
Review of Technical documents received from manufacturing site such as development reports, BMR, BPR, specifications, method validation, process validation, change control etc.
Coordinating with R&D, QA, Production, ADL and Purchase for collection of Technical data for the compilation as per the guidelines
To ensure timely response of deficiencies raised by Agency on ANDA’s
Handling of Change Controls and deviations for their impact on respective regulatory submission.
Review, compilation and authoring of CMC, Bio Pharmaceutics, Labeling, Module 1 documents.
Authoring and review of ANDA dossier/deficiencies in eCTD format.
Time & venue :
18th Dec, 2021
10.00 AM – 3.00 PM
Alkem Laboratories Ltd (R&D), C-6/1 C-6/2 C-17/7, Dist, Industrial Estate, Opposite Taloja Police Station,Taloja, Navi Mumbai, Maharashtra 410208
Contact – Snehal Parkhi (HRD)
All the candidates interested to attend walk in are requested to take adequate COVID protection measures as per the government norms.