Specialist - Clinical DQA

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.

We are seeking a detail-oriented Clinical Specialist DQA (Clinical Quality Assurance) to join our organisation in Hyderabad, India. The successful candidate will be responsible for ensuring the integrity, accuracy, and reliability of our pre-clinical and clinical study conduct. Key responsibilities include:

• Plan and perform vendor qualification and audits for pre-clinical, clinical, and In-vitro studies service providers
• Post study audit (off-site and on-site) of Pre-clinical, Bioequivalence studies and Clinical studies.
• Maintain and update the Quality Management System for Global Clinical Management
• Develop, review, and approve SOPs for pre-clinical, clinical, and QA processes
• Execute Clinical audit programs and support health authority inspections
• Review regulatory deficiencies and support cross-functional teams in preparing responses
• Analyse deviations, incidents, and root causes, implementing corrective and preventive actions for clinical studies
• Self-Inspection of Global Clinical Management team

The ideal candidate will have a strong background in GCP, GLP, and quality management processes, with the ability to work efficiently in a fast-paced environment.

• Master's degree in Pharmacy or Clinical research
• 8-12 years of experience in clinical quality assurance or related field
• Strong proficiency GCP and GLP
• Hands-on experience with bioanalytical analysis
• Proven track record of working with large-scale data sets and data warehousing
• Excellent understanding of data governance principles
• Knowledge of current Regulatory updates and Inspections
• Strong analytical and problem-solving skills
• Attention to detail and ability to work efficiently in a fast-paced environment
• Excellent communication and collaboration skills
• Ability to work independently and as part of a team
• Strong organizational skills and ability to manage multiple projects simultaneously

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. The 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