Krushika jani

Solid/Liquid Dosage Forms for the USP, Europe, and Canada Markets.

• Conducted extensive literature and patent surveys for APIs and finished products, aligned with regulatory requirements.
• Designed and executed pre-formulation studies and product development trials with robust manufacturing processes.
• Led formulation and process optimization trials using Quality by Design (QbD) principles.
• Developed and optimized solid and liquid oral dosage forms, including immediate-release tablets, modified-release tablets, suspensions, emulsions, and syrups.
• Successfully led the development of a critical extended-release suspension project, improving taste, drug binding properties, and dissolution profile, with a bioequivalence study submission.
• Demonstrated expertise in pharmaceutical equipment, including:

Manufacturing equipment: Tablet compression machines(Eliza Press, Cadmach), coating machines (Auto coater), roller compactor, fluid bed processors (ACG), Rapid Mixer Granulator, Blender and Multi mill.

Analytical instruments: Disintegration tester, moisture analyzer, sieve shaker, tapped density tester, and autoclave.

• Collaborated effectively with analytical, QA, and regulatory affairs teams to ensure smooth project execution.

• As a Quality and Regulatory Trainee at SMC Medical Manufacturing Pvt Ltd, I gained practical experience in quality assurance and regulatory compliance in the medical manufacturing industry
• I developed a strong understanding of regulatory requirements and standards such as ISO 13485 and FDA regulations
• I also gained hands-on experience in quality control processes, including inspection, testing, and documentation
• Through this experience, I developed my problem-solving, and attention to detail skills, and gained valuable experience in a dynamic and fast-paced environment