Packaging Scientist at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Verification Testing, Risk Analysis, Change Control Management, Medical Devices, Combination Products, ISO Standards, Device Testing, Vendor Management, Technical Package Preparation, Packaging Documentation, Technology Transfer, Stakeholder Communication, Training, Regulatory Compliance, Product Development, Team Collaboration

Industry

Pharmaceutical Manufacturing

Description

Company Description 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 Description Author and/or participate in preparation of Design History File (ISO 13485) and Risk Management (ISO 14971) for drug-device combination products such as prefilled syringes, autoinjectors, pen injectors Support preparation of technical package for Notified Body Opinion submissions Preparation and execution of design verification protocol and test reports for combination products such as pen injectors, autoinjectors and prefilled syringes Device primary functions testing with respect to relevant ISO standards (ISO 11608, ISO 11040, ISO 6236 etc.) 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. Participating in execution activities for CB, EB, method developments & verifications. Identify and plan for device testing for primary container as per relevant USP and Ph.Eur requirements Manage vendor interactions and communication for device suppliers, primary packaging component suppliers, artwork development, secondary packaging development, device assembly and testing Facilitate technology transfer of medical device and combination products from development to commercialization 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. Qualifications Bachelor’s or Master’s degree in Science, Engineering, Biomedical, Packaging, or a closely related technical field, coupled with minimum 2 years of hands-on experience in the pharmaceutical or medical device industry Experience with design verification testing Relevant experience in medical devices or combination products, design control, risk analysis and change control management Experience in combination product design verification (ISO 11608, ISO 11040), design controls (ISO 13485), risk management (ISO 14971) Experience with medical device or combination product commercialization, operations support, and materials/components Experience with pen injectors, autoinjectors or other complex drug-delivery systems and associated pre-filled syringe systems or cartridges. 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 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. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Responsibilities

The Packaging Scientist will author and participate in the preparation of design history files and risk management for drug-device combination products. They will also manage vendor interactions and facilitate technology transfer from development to commercialization.