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Chief Manufacturing Statistics Leader

2 weeks ago

Hyderabad, Telangana, India beBeeStatistician Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Senior Statistician Job Opportunity

This is a senior statistician position that requires leadership in the development and deployment of statistics strategy for manufacturing networks.

Main Responsibilities:
  • Support definition of Internal Release Limits (IRL) and Out-of-Expectation (OOE) limits by analyzing process validation data and statistical analysis.
  • Develop best practices roadmap and harmonize application for NTO platform in alignment with corporate and regulatory guidelines, ensuring compliance and quality.
  • Perform statistical analysis of process validation data to demonstrate validity and equivalence, utilizing advanced statistical techniques.
  • Plan and evaluate Design of Experiments (DoEs) in the frame of the Novartis Quality by Design (QbD) validation strategy, identifying key factors and optimizing processes.
  • Implement and apply Statistical Process Control principles, such as control charts and pattern recognition techniques, to monitor and improve process performance.

Required Skills and Qualifications:

  • Minimum 10 years of experience in applied statistics, with at least 2 years in manufacturing environments.
  • Proven process understanding, including Pharma, GMP, and Regulatory aspects.
  • Experience with multivariate data analysis and Design of Experiments (DoEs), with a strong background in statistical modeling and analysis.