Quality by Design (QbD) Specialist

Good Health Can’t Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

We are seeking a detail-oriented and analytical Specialist Quality by Design (QbD) to join our team in Hyderabad, India. In this role, you will be responsible for implementing and maintaining QbD principles throughout our pharmaceutical manufacturing processes, ensuring high-quality products and regulatory compliance.

• 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)
  

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered