Quality Assurance Associate - Drug Product

Dr. Reddy's Laboratories; Hyderabad; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Dr. Reddy’s Laboratories is seeking a Quality Assurance Associate for Drug Product with 8–10 years of injectable product experience. The role focuses on GMP compliance for formulation, filling, and packaging lines, and involves review of QA documents, CAPA handling, and audits.

The candidate should hold a Bachelor’s or Master’s in Life Sciences and demonstrate strong communication, analytical skills, and cross-functional collaboration within a global biosimilars context.

Qualifications

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.

Responsibilities

• Ensure shop floor GMP compliance across Formulation, Filling, Optical Inspections and Packaging lines.
• Review GMP records and ALCOA-compliant documentation.
• Review MFRs, BPRs, SOPs and validation protocols for Formulation, Filling and Packaging.
• Investigate deviations and market complaints; perform line clearance checks.
• Participate in Internal and external audits; support CAPA processes.
• Compile Annual Product Quality Reports (APQRs) for commercial products.

Skills

Communication

Analytical thinking

Cross-functional teamwork

Education

Bachelor's or Master's in Life Sciences

Job description

Quality Assurance Associate - Drug Product

• Full-time
• Job Family: Quality
• Sub Job Family: Quality Assurance
• Business unit: Biologics

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 becauseGood 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.

Responsibilities

• To Ensure shop floor compliance by involving in Line Clearance activities for Formulation, Filling, Optical Inspections and Packaging Activities.
• To monitor and ensure that all activities involved in Formulation, Filling, Optical Inspections and Packaging Activities are in compliance with GMP and Standard operating procedures.
• Review of Aseptic Media Fill Simulation Protocols and Reports. To Support for the Execution of Aseptic Media Fill Simulation activities.
• To Perform periodic verification of GMP records to ensure that data generated and documented at GMP floor are in compliance with ALCOA principle.
• Responsible for ensuring the drug product related Control Samples compliance.
• To ensure and comply the finished product time out of refrigeration and material management with in Production- Packing.
• Review and Approval of MFRs, BOMs, BPRs, SOPs (New, Revised & Executed Batch Records) and Validation protocols related to Formulation, Filling and Packaging Operations.
• Review of drug product MFR/BPR’s for commercial and developmental products manufactured in cGMP facility.
• Review of Change Controls, Incidents, CAPAs.
• To Perform investigation for deviations, and market complaints. To carryout/execute timely line clearance and carry out routine and non- routine spot check on shop floor.
• To Participate External and Internal Audits.
• Compilation of Annual product quality report (APQRs) for commercial drug products.
• Execution of Area, Process and Product change over line clearances for filling and packaging related activities.
• Sampling of Drug Product samples for LRA testing.
• To support for out of specification/out of limit (OOS/OOL) investigations related to product and environments.
• To Perform System / Process, audit trial for manufacturing equipment.
• To support, monitor Transport Validation activities.
• To verify temperature data of export shipments.

Educational Qualification - Bachelor's or Masters in Life Sciences

Minimum Work Experience- 8to 10 years of experience in a pharmaceutical company in Injectable products.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.

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 catalise 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/#!/

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