AGM Formulation & Development Nagpur OSD Plant

Job Description

Working in Formulation and Technology transfer (OSD) Development and technology transfer of product for Regulated market. Projects management as per timeline based on clients for delivery of products. Preparation and Review of Optimization, validation protocol and reports. Application for test license, import license and activities to obtain product clearance. Literature and patent search, analytics, review scientific discussion and documentation (SOP, QQF, MFI, BOM, Optimization protocol). PROFESSIONAL EXPERIENCE Review of BMR, BPRs, PVP, PVRs Review and analyze CPPs, CQAs Execution of Preformulation trials and trials batches for formulation development, scale up and validation batches at plant. Product development report Preparation and review as per ICH Q8 (R2) Dossier Documents Support for product approval. Query response and justification preparation for different (Ministry of Health) to obtain product approval (E.g., Brazil, Turkey, Malaysia, Ethiopia, Philippines, Spain, Malta) if interested mail cv at :- neetij@selectsourceintl.com