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Executive

3 months ago

Vadodara, Gujarat, India SUN PHARMA Full time

Job Description

  • Experience needed in Formulation R&D product development including Injectables in Novel drug delivery systems, Lyophilized products, and Solution products.
  • Conducting literature searches such as Summary Based Approval (SBA), reviewing Patents, and researching articles relevant to project requirements and understanding Regulatory guidance.
  • Conducting pre-formulation and formulation developmental experiments with a Quality by Design (QbD) approach and documenting drug product manufacturing experiments in a Laboratory notebook.
  • Creating product development protocols, stability study protocols and reports, preparing SOPs for laboratory equipment, maintaining critical data records for regulatory audits.
  • Preparing documents for Technology Transfer including Master Formula, Risk assessment, Failure mode effect analysis, and Safety data sheet.
  • Supporting cross functional activities at the plant for Scale-up/ Exhibit batches/ Commercial batches for assigned projects.
  • Compiling Product development report (PDR), Risk assessment reports, and various project reports.