Harshil M Parikh

Teva Pharmaceuticals, USA

Title: TBA

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Biography

Harshil M Parikh is a Highly motivated Formulation Scientist with excellent knowledge and research experience in developing semi-solid, liquid and injectable products/ process development.

• Working on different pre-NDA, ANDA/ paragraph IV projects on liquid, semi-solid, inhalation, foam and injectable formulationsWork on multiple projects with multiple sites
• Evaluate physicochemical properties of raw materials and formulations including but not limited to viscosity, pH, specific gravity, and microscopic examination
• Design experimental study with QbD concept
• Perform lab scale batches and transfer to commercial level
• Optimize manufacturing process
• Draft documentation for tech transfer and commercial batches as per FDA and ICH guidelines
• Perform stability study according to FDA guidelines for ANDA application
• Work with multiple site and third parties projects
• Thorough knowledge of cGMP (Good Manufacturing Practice) and GLP(Good Laboratory Practice)
• Draft SOP and make necessary changes, if needed
• Review and make some change in commercial OTC batches, if needed
• Prepare BPCR (Batch Production(Manufacturing) Control Record) for exhibit batch
• Execute exhibit batch for FDA application.
• Good ability to work cross functionally and accurately communicate risks and requirements.
• Strong technical and communication skills.

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