MSAT Specialist

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because 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

We are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes, including authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis. Your role will involve active participation in technology transfers, continuous improvement initiatives, and ensuring compliance across manufacturing operations.

Roles & Responsibilities

• Responsible for Validation which shall include: Preparation/Review/Approve of MPR. Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report.
• Responsible for Tech transfer which shall include: Coordination with Vendor/cross functional teams for Tech transfer activities. Execution of Tech transfer products at Receiving Units. 
• Responsible for QIP which shall include: Identifying root cause for QIP. Execution of QIP. Conclusion/Recommendation of QIP.
• Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT.
• Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements.
• Follow up & coordinate with cross functional team for execution of validation.
• Give the input for the monthly reporting system, participate in the internal & external audits, present the documents to auditor’s/inspection team.

Educational qualification: Masters/Bachelors/Ph.D in pharma

Minimum work experience: 6-8 years of experience in Process development / MSAT / Tech transfer

Skills & attributes:
Technical Skills

• Experience in the scale up/ technology transfer of products in relevant dosage forms or technologies. (OSD)
• Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches. 
• Knowledge of International Council for Harmonization (ICH) guidelines related to Product development or Process Development.

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
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.