Quality Assurance Associate - Drug Product

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.

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

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.

Requirements

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