Team Member - QbD (68523)
2 years ago Engineering Mumbai 256 views Reference: 21313Job Details
Requisition ID 68523
Implementation of QbD principles during formulation development and scale-up to ensure high quality products that consistently deliver the intended performance during technology transfer and manufacturing
Accountabilities
- Implement QbD principles at various stages of product development and scale-up; prepare action plan for risk identification, risk assessment; and propose risk mitigation & control strategy, in line with regulatory requirements, within the stage gate timelines through brain storming sessions with stakeholders, to ensure robust quality of products and processes
- Review of development report
- Identify factors and levels for DOE and select the design; analyze data for finding out the design space within the QbD framework for optimization of formulation and process
- Apply statistics for understanding the product
- Apply Process Analytical Technology (PAT) tools in Formulation Development for robust process design (optional)
Education Qualification
B. Pharm or M. Pharm (Preferred)
Relevant Work Experience
At least 5-10 years of experience in Formulation Development with exposure to QbD, DoE, Statistics and Process Analytical Tools (Preferred)
Job Location
Mumbai
Competencies/Skills
Communication Skills (clarity of thought, comprehension)
Likely potential for growth
Job / Product / Technical Knowledge / Pharma domain knowledge
Presentation & Interpersonal skills (If applicable)
Managerial or People Management skills
Safety awareness (If applicable)
Relevance of Previous Experience
Comprehension, Analytical & Problem solving abilities
Productivity & Result Orientation (If applicable)
Attitude
Qualification fitment
Sales drive (If applicable)
Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
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