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.

External manufacturing Quality assurance

- Conduct quality due diligence and qualification assessments of prospective insourcing and outsourcing partners.
- Establish, review, negotiate, and maintain Quality Agreements with external manufacturing, testing, and service partners.
- Ensure compliance with Quality Agreement commitments through periodic monitoring and governance activities.
- Receive, evaluate, approve, and track change notifications from external partners, including assessment of quality, regulatory, and supply impacts.
- Review and monitor quality events such as deviations, investigations, CAPAs, complaints, and OOS/OOT events associated with external operations.
- Perform quality risk assessments and provide GMP oversight for outsourced manufacturing and testing activities.
- Participate in audits, partner performance reviews, and inspection readiness activities.
- Maintain oversight of external partner quality performance through metrics, periodic reviews, and escalation of critical quality concerns.
- Collaborate with cross-functional teams to ensure effective management of quality systems and compliance requirements related to external manufacturing.

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

Minimum work experience : 5 years of industrial experience with specific operational experience in Manufacturing, Quality Assurance or Development

Skills & attributes

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.

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.

Requirements

Qualification and lifecycle management of service providers and consumable vendors; Handling of material complaints.; Periodic qualification of vendors and service providers by audits; Establishment and periodic renewals of quality agreements; To ensure timely and compliant qualification of vendors and materials used in commercial manufacturing.; To perform periodic verification of GMP records in compliance with ALCOA principle; A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.; In-depth 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.; Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements.; Ability to understand and implement organizational policies and ensuring compliance.