Team Member - Quality Assurance (Validation)

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.

Job Summary

• Review of Technology transfer documents, Review of process and cleaning trial and validation documents, nitrosamine impurity assessments, CPV reports, batch production records and cleaning records etc.
• Reviewing and approving Quality Risk Management processes to identify, assess, and mitigate risks to product quality and patient safety.
• Performing SAP activities and updating Bills of Materials (BOM) and recipes accurately to reflect product specifications and changes.
• Monitoring plant activities related to trial and Validations.
• Supporting marketing queries and DMF filings.
• Ensuring compliance with good manufacturing practice, GxP, and other regulatory requirements through self-training and adherence to established procedures.
  

Qualifications

Educational qualification:

• Knowledge of process and cleaning validation activities, sampling and relevant standards.
• Proficiency in performing line clearance, material verification, start-up checks, and in-process checks following batch manufacturing and packing records.
• Experience in timely sampling and testing of in-process, reserve, and finished samples, as well as stability samples and environmental monitoring.
• Skilled in reviewing batch manufacturing and batch packing records, ensuring accuracy and certification after execution.

Behavioural Skills

• Attention to detail in performing line clearance, verification, and record reviews.
• Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities.
• Communicates effectively with team members and stakeholders regarding batch-related activities and compliance.
• Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification.
• Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.
  

Additional Information

About the DepartmentGlobal Manufacturing Organisation (GMO)