Job
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 Job Summary We are looking for an individual for the SIT Team to oversee the investigation of level 2 and 3 incidents, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the SAP incident log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of level 2 and 3 incidents from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports. • Your role involves active participation in investigating valid OOS (Out of Specification) and other relevant cases, working closely with CFT members to determine root causes, CA, PA, and report writing. • You will review level 1B incidents, providing constructive feedback for improvement. • Your responsibilities include periodically assessing the trending of level 1A incidents, highlighting or escalating key observations, regularly reviewing the SAP incident log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports. • You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations. Qualifications Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline Minimum work experience : 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance Skills & attributes: Technical Skills • In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA). • Expertise in investigating valid OOS and other relevant cases. • Familiarity with reviewing SAP incident log and ability to perform classification of data. • Ability to craft comprehensive investigation reports. • Experience in providing necessary support for regulatory inspections related to investigations. • Knowledge of regulatory requirements pertaining to incident investigations. Behavioural Skills • Ability to collaborate closely with CFT members. • Analytical mind set for identifying root causes and developing effective solutions. • Strong problem-solving skills and attention to detail in reviewing incidents, reports, and trending data and implementing corrective actions. • Effective communication skills for report writing and escalation of key observations. • Commitment to ensuring compliance with regulatory requirements in investigations. • Ability to offer necessary support to the site in readiness for or during regulatory inspections. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. 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/#!/ Show more Show less
