Quality Assurance Associate

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 summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves supporting in establishing the Quality Management Systems, review and monitoring the performance of Quality Management Systems.

Roles & Responsibilities

• Review of procedures relating to Quality Assurance and implementing the global procedures at site with effective training.
• Deviation Management System :
• Establishing the deviation management master data in the application and management of changes and facilitating the implementation to site.
• Review daily logged devaitions for their category and adequacy of investigations and taking appropriate actions with line QA.
• Escalating the serious deviations for their immediate action towards Quality Defect Notification and identifying the oppurtunities for Quality Risk Assessment.
• Dip-stick review of closed investigations for their appropraite root cause identification, adequate CAPA.
• Quarterly Trend analysis of deviations for their repeatetive nature and identifying the oppurtunities for holistic CAPAs.
• CAPA Management System :
• Review of adequacy of Corrective Actions and Preventive Actions and periodic discussing with line functions for their adequacy.
• Change Management System :
• Review of change controls for their category, adequacy of supportive documents, post change effectiveness requirements.
• Coordinating the change control review meeting for all signficant changes across QA Leads and QPs and review of change proposals for change notification requirements.
• Tracking the change controls for regulatory notification for their implementation. 
• Maintenance of daily routine logs and developing the team to analyse the data in an appropraite meaningful manner.
• Facilitating the training across the quality management systems including the digital systems and processes.
• Quality Risk Management System :
• Review of Quality Risk Assessments for their mitigiation plans and creating the risk register for site.
• Communicating the high risks to the senior leadership team.

Educational qualification: A B.Pharm. or Post-Graduation (Life Sciences)

Minimum work experience: 6-8 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering.

Skills & attributes:

Technical Skills
• A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
• Ability to develop simplified and robust quality systems.

Ability to trouble shoot the issues with simple solutions.

Knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.
• Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.
• Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.
• Ability to understand and implement organizational policies and ensuring compliance.

Behavioural skills
• Demonstrates a commitment to continuous learning.
• Strong communicating and influencing skills.
• Displays analytical and logical thinking abilities.
• Is self-motivated and takes initiative.
• Adaptability to the work environment, along with being a team player.
• Ability to go beyond boundaries, showcasing a proactive and innovative approach.

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/#!/