Quality Assurance Associate

Job Description Supplier qualification and life cycle management 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 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. Qualifications 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: Technical Skills • 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. 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. Additional Information 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/#!/