Team Member - Site Investigation Team

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 looking for an individual to work with  Site Investigations  (Quality Assurance) ensuring the conducting the effective investigations and root cause analysis and drive them towards closures in timely manner with adequacy with support of Lead/Group Lead - Site Investigation Team.

Key Responsibilities:

1. Investigations & Root Cause Analysis:
   • Oversee and direct investigations of quality issues, deviations, and out-of-specification (OOS) results.
   • Ensure thorough and timely root cause analysis for identified issues.
   • Drive investigations to closure with adequate corrective actions and preventive measures.
2. Cross-Functional Coordination:
   • Provide direction to cross-functional teams involved in investigations and root cause analysis.
   • Facilitate communication and coordination among departments to address quality issues effectively.
3. Reporting & Documentation:
   • Ensure thorough documentation of investigations, root cause analyses, and CAPA actions.
   • Prepare and present reports on investigation outcomes and CAPA effectiveness to senior management.

Educational qualification: A Post-Graduation in Sciences (Bioprocess, Biotechnology, Life sciences), Pharmaceuticals. 

Minimum work experience: 6 to 10 years of experience in various functions such as Manufacturing, Quality Control, Quality Assurance, Engineering, Research and Development in pharmaceutical and biopharmaceutical industries

Skills & attributes:

Technical Skills
• Strong comprehension of process and analytical investigations and Understanding of counter functions within the organization and their relationship to quality processes.
• Familiarity with quality assurance processes and investigation and root cause methodologies.
• Deep understanding of cGMP (Current GMP) across various phases of the product life cycle (Process and Analytical).
• Knowledge of quality management principles and practices, including quality control and quality assurance.
• In-depth knowledge of both the products and the processes involved in the Bio Pharma and Pharma sectors.

Behavioral skills
• Strong communication and influencing skills.
• Commitment to continuous learning and coaching.
• Displays risk-based decision-making skills.
• Excels in building and leveraging relationships, with a focus on strong team-building.
• Commitment to innovation and effective problem-solving.
• Prioritizes integrity in all aspects of work.

About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

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/#!/