AUROBINDO PHARMA LTD is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over USD 2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.
Department : Regulatory Affairs (Oral Solids) - CMC
Experience : 04 to 10 Years
Specifications : Must have a good exposure with US Market
Job Description
Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3, Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms, Preparation, review and compilation of Supplements and Amendments. Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports master formula cards, master packaging cards etc. Review of analytical documents (like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols (multi point, multimedia and alcohol dose dumping etc), stability protocols and stability data.
Work Location : APL Research Center I Sy.No.313&314, Bachupalli Medchal- Malkajgiri dist. Hyderabad, Telangana-500090
Interested candidates can send their profiles to SravanKumar.Bhimuni@aurobindo.com
Last Date : 14th August, 2023
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