Quality by Design (QbD) Specialist

Role Overview: As a Specialist Quality by Design (QbD) at Dr. Reddys Laboratories Ltd., based in Hyderabad, India, you will play a crucial role in implementing and maintaining QbD principles in pharmaceutical manufacturing processes. Your primary focus will be on ensuring high-quality products and regulatory compliance through the development and implementation of QbD strategies for both new and existing products. Collaborating with cross-functional teams, analyzing complex data sets, and providing technical expertise will be key responsibilities in this role. Key Responsibilities: - Develop and implement QbD strategies for new and existing products - Conduct risk assessments and design of experiments (DoE) to optimize manufacturing processes - Analyze and interpret complex data sets to identify critical quality attributes and process parameters - Collaborate with cross-functional teams to integrate QbD principles into product development and manufacturing - Develop and maintain documentation related to QbD initiatives, including risk assessment reports and control strategies - Provide technical expertise and training on QbD methodologies to team members - Monitor and evaluate the effectiveness of QbD implementation, recommending improvements as needed - Ensure compliance with regulatory requirements and industry standards related to QbD - Participate in regulatory inspections and audits, providing QbD-related information as required Qualifications: - Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, or a related field - 4-8 years of experience in QbD implementation within the pharmaceutical or biotechnology industry - Strong understanding of Quality by Design (QbD) principles and methodologies - Proficiency in statistical analysis, data interpretation, and risk assessment techniques - Experience with process analytical technology (PAT) and design of experiments (DoE) - In-depth knowledge of pharmaceutical manufacturing processes - Understanding of regulatory requirements (FDA, EMA) related to QbD implementation - Excellent problem-solving skills and attention to detail - Strong communication and collaboration abilities - Experience in process development and optimization - Proficiency in relevant software tools for data analysis and reporting - Certifications in Six Sigma or Lean Manufacturing (preferred),