MSAT 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.

Job Summary

Technology Transfer, Troubleshooting & Continuous Improvement

• Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM).
• Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities.
• Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers.
• Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
• Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
• Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
• Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving.
• Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs).

Cleaning Validation:

Analytical Support:

• Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance.
• Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives.

Subject Matter Expertise:

Qualifications

Educational qualification:

• Good Interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.
• Strong analytical and problem-solving skills to address challenges.• Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.• Takes responsibility and maintains a disciplined and agile approach to execution.

Additional Information

About the Department

Integrated Product Development Organisation

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages

Benefits Offered