Job
Description
Role Overview: You are sought after to join the team at Dr. Reddys Laboratories Ltd. as a Specialist Quality by Design (QbD) in Hyderabad, India. Your primary responsibility will be to ensure the implementation and maintenance of QbD principles throughout the pharmaceutical manufacturing processes to guarantee high-quality products and regulatory compliance. Key Responsibilities: - Develop and implement QbD strategies for both new and existing products - Conduct risk assessments and design 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, such as 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, suggesting improvements when necessary - Ensure compliance with regulatory requirements and industry standards related to QbD - Participate in regulatory inspections and audits, providing QbD-related information as needed 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) Additional Details: Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company with a vision to accelerate access to affordable and innovative medicines. With a strong foundation in deep science, progressive people practices, and robust corporate governance, the company is committed to sustainability in all aspects of its operations. The company's Integrated Product Development Organisation drives innovation and accessibility in healthcare solutions, with capabilities in API, Formulations, Clinical, Intellectual Property, and Regulatory Affairs. The company's work culture is centered around the belief that "Good Health Can't Wait," with a focus on empowering people to lead healthier lives. Dr. Reddys fosters a culture of empathy and dynamism, where individual abilities are supported within a framework of teamwork and shared success. The company offers benefits that align with industry standards and actively supports career growth and professional development through personalized learning programs. For more information about career opportunities at Dr. Reddys, visit their career website at [https://careers.drreddys.com/#!/](https://careers.drreddys.com/#!/) Role Overview: You are sought after to join the team at Dr. Reddys Laboratories Ltd. as a Specialist Quality by Design (QbD) in Hyderabad, India. Your primary responsibility will be to ensure the implementation and maintenance of QbD principles throughout the pharmaceutical manufacturing processes to guarantee high-quality products and regulatory compliance. Key Responsibilities: - Develop and implement QbD strategies for both new and existing products - Conduct risk assessments and design 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, such as 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, suggesting improvements when necessary - Ensure compliance with regulatory requirements and industry standards related to QbD - Participate in regulatory inspections and audits, providing QbD-related information as needed 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 assessm
