Environment monitoring of aseptic area, Water sampling and testing, Sterility testing, Bioburden analysis and MLT analysis, Bacterial endotoxin test, Media preparation and handling.
Good understanding of medical affairs function. Understanding of local regulatory policy and industrys code of practice related to drug registration, pharmaceutical promotion and clinical research.
Responsible for executing technology transfer activities for injectable dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials, and equipment.
Handling and maintaining of fully auto mated Glatt integrated line (Horizontal)/Octagonal Blender / Bin Blender / Sifter / Mill Fette Compression machine / Capsule filling machine with line equipment / Automated Tablet and Capsule visual