Amneal is a global essential medicines company powered by a robust U.S. generics business. Amneal is a growing branded business with deepening portfolios in institutional injectables, biosimilars and select international markets including India.
HIRING for R&D - Technology Transfer (MS&T) Injectable ; Global Regulatory Labeling
M.Pharmacy, preferably a PhD in Pharmaceutical sciences Join team for ground breaking discoveries in Drug Metabolism & Pharmacokinetics; Opportunities for talented individuals to join us as senior research associate/research scientist- In Vivo, senior research associate/principal scientist- In Vitro ADME and research associate/group leader- bioanalysis.
Responsible for Authoring and review of dossiers for submission to US, Canada, Europe, Australia, South Africa and other regulated markets. The Company focused on the emerging markets of Latin America, Caribbean, Francophone and Southern Africa and is today one of the leading suppliers of Pharmaceuticals in these regions, with over 2800 product licenses across the globe.
Review quality Dossiers in CTD format for new Generic drug submissions, in-line with the guidance and templates. Compile responses to deficiencies and deficiency management for the given portfolio of products.
Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.
Must have handled critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. Ensure that the products are manufactured as per the cGMP.
Graduate - Science or General B.Pharma, D.Pharma, MBA. Minimum 6 months experience in sales. Dr. Reddys Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India.
Prepare and execute of Process validation, Hold time study protocol and compilation of Process validation reports. To monitor Equipment Qualification, HVAC and Utility validation schedule as per VMP.