To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form based on QbD approach.
Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval
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
Must have Expertise in OSD / Sterile / Liquid. Handling of change controls related to Master Production / Packaging / Validation documentation via QMS Track Wise.