Scientific Publisher

Job description Preparation of documents and facilitation of documentation management in R&D while following established guidelines for correctness, completeness and clarity. Preparation of documents such as Manufacturing Batch Records, Study Protocol and Reports, Stability Protocols, Product Development Report, response to regulatory queries, based on the scientific input from the Formulation team. Preparation of documents such as, Test Procedures, Specifications, Method Evaluation Reports, Validation Protocols and Reports, Risk Assessment Documents, etc based on the scientific input from the Analytical team. Preparation of high impact presentations including graphs, charts and statistical analysis of data. Submission of documents for signatures and coordinating their flow, archival and retrieval to ensure timely flow and publish monthly performance metrics. Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements. Perform other duties as assigned or delegated. Comply with FDA guidelines/Company Policies of Data Integrity. Perform necessary transactions in SAP and other project / manufacturing systems, create material master, recipe, bill of materials and other changes as per change control. Generate the standard reports from the SAP and other software