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jobs description

Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats.Setting specifications of API process development, knowledge of litigation related to Drugs and Cosmetics Act.Filing annual updates and amendments to various regions of submitted DMFs.Handling queries obtained from different regulatory agencies and customers.Compilation, pre...paration and review of Technical Package of API's.Compliance to audits of regulatory bodies especially USFDA and EU.Generation of documents from R&D, Production, QC and QA of newly developed API's.Responsible for record keeping and to ensure correctness of records pertaining to department.Responsible for all type of computer work and follow-ups.Carrying out the initial assessment of Vendor Questionnaire and relevant documents.Maintain housekeeping and cleanliness of plant.To impart scheduled trainings of ICH guidelines pertaining to department.Desirable: Minimum 03 to 05 years working experience B. Pharma/M. PharmaLocation: Murthal, Sonipat.Posting Date: 11/09/2021
Surat Gujarat India

salary-criteria

Apply - Pharmacist Jobs in True Drug Pharmacy - Surat, Gujarat, India