AGM-Quality by Design

AGM-Quality by Design

Job description

  • To provide inputs for designing QbD based experimentation strategy for formula and process optimization,
  • data modeling and data analysis with Design Expert by Stat-Ease and JMP, interpretation of results and provide way forward.
  • Establishment of scale correlation principles from laboratory scale to pilot scale and their implementation during drug product development
  • Evaluation of process analytical technology tools in product development
  • To guide review of various QbD elements and to provide inputs/recommendations for risk mitigation plans
  • Review of product development report from QbD perspective
  • Provide scientific insight on the regulatory queries and to provide support to regulatory affairs department
  • for timely response and approval.
  • Provide training to supervise Associate Scientists/Research Associates/Trainees with respect to QbD principles and their implementation in product developments.
  • Establishment of systems and SOPs for creating harmonized practices

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