About the Company: 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 transparencyDr 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.

About the Role: Preparation of design verification protocol and test reposts for combination products such as pen injectors, autoinjectors and prefilled syringes. Author and/or participate in preparation of Design Controls (ISO 13485) and Risk Management (ISO 14971) for drug-device combination products Support preparation of technical package for Notified Body Opinion submissions Manage vendor interactions and communication for device suppliers, primary packaging component suppliers, artwork development, secondary packaging development, device assembly and testing Preparation of packaging documents – Material code, FG code, Bill of Materials, MPC, test method development, test method verification, artworks, print proofs, transport study, transfer checklist, drawings, layout, trials reports, specifications, STP etc. Develop device assembly and automation for manufacturing. Evaluate concepts, ensure development and participate in equipment qualification Identify and plan for device testing for primary container as per relevant USP and Ph.Eur requirements Device primary functions testing with respect to relevant ISO standards (ISO 11608, ISO 11040, ISO 6236 etc.) Lead technical investigations of medical device and combination product Facilitate technology transfer of medical device and combination products from development to commercialization Application of statistical tools for data analysis Supporting global and site-specific projects, including those related to combination products and drug delivery systems Keep current with ISO and FDA regulations respective to combination products. Train new and existing employees on Combination Product Requirements, processes, and procedures Keep stake-holders and team members informed with effective communication. The key stakeholders include Internal and External Manufacturing Sites, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers.

Key Responsibilities: Preparation of design verification protocol and test reposts for combination products such as pen injectors, autoinjectors and prefilled syringes. Author and/or participate in preparation of Design Controls (ISO 13485) and Risk Management (ISO 14971) for drug-device combination products Support preparation of technical package for Notified Body Opinion submissions Manage vendor interactions and communication for device suppliers, primary packaging component suppliers, artwork development, secondary packaging development, device assembly and testing Preparation of packaging documents – Material code, FG code, Bill of Materials, MPC, test method development, test method verification, artworks, print proofs, transport study, transfer checklist, drawings, layout, trials reports, specifications, STP etc. Develop device assembly and automation for manufacturing. Evaluate concepts, ensure development and participate in equipment qualification Identify and plan for device testing for primary container as per relevant USP and Ph.Eur requirements Device primary functions testing with respect to relevant ISO standards (ISO 11608, ISO 11040, ISO 6236 etc.) Lead technical investigations of medical device and combination product Facilitate technology transfer of medical device and combination products from development to commercialization Application of statistical tools for data analysis Supporting global and site-specific projects, including those related to combination products and drug delivery systems Keep current with ISO and FDA regulations respective to combination products. Train new and existing employees on Combination Product Requirements, processes, and procedures Keep stake-holders and team members informed with effective communication. The key stakeholders include Internal and External Manufacturing Sites, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers.