Roshaiah

Experience

1. Senior Manager

   Fleming Laboratories

   Dec 2023 — Present · Hyderabad, IN

   Project Execution, Product Profile, ROS, Flow chart, Brief manufacturing process, List of raw materials, Stage wise complete process details, CPP and justification, Holding, Hazop study of reaction mass & Holding of Intermediates, RM specification, All new raw materials testing methods, Stage wise in-process specifications, and testing methods, Intermediate specifications, and testing methods. Finished product specifications, finished product testing methods, Solubility data for key starting materials, key intermediates and finished product, Cleaning procedure for all stages, Consumption Co-efficient per Kg All stages, mass balance and effluent generation. Lab validation experimental data and COA’s, Solvent recovery process & specifications, Reprocess/Rework method. MSDS for new raw materials and Intermediates. Identification and properties of hazardous chemical in the new product. Handling procedure for hazardous chemicals to identification and handling the hazardous chemicals, Procedure for safe disposal of hazardous chemicals during the scale up/commercialization, finished product MSDS.Reaction calorimetry measures. Powder safety evaluation data, Impurities origin / formation & Control, Genotoxic assessment report, Nitrosamine assessment report, Optimization and Negative Experiments data, Working standard Characterization for Key starting materials, Intermediates and Final API with COA’s, Final API packing configurations and storage conditions. Design of experiments.BPR’s, Developmental reports, Technical Reports, Impurity profile tables, Technology transfer, Quality and Documentation, Technical Reports, Impurity profile tables, as per ICH, People Management, request for proposal, Lab Safety and Compliance,

Education

• Osmania University

  Master's degree

• Govt. City College

  Bachelor of Science (B.Sc.)