RS - F&D(Parenteral /Ophthalmic )

Roles and Responsibilities

• Literature search and patent search.
• Selection of API source, Excipients, Equipment's and packing materials.
• Pre formulation studies.
• Finalization of stable formulation process.
• Initialization and review of stability studies as per ICH Guidelines and requirements.
• Finalizing the MFR [master formula record] and specifications.
• Preparation of PDP and PDR by using QbD as per regulatory requirements.
• Execution of Exhibit /Submission batches and optimization/Scale up batches on plant Level.