Team Leader - QA

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 a candidate to ensure compliance in batch manufacturing and packing processes, including line clearance, material verification, and in-process checks. Responsibilities involve reviewing and approving master batch records, overseeing technology transfer and exhibit batches, and managing QMS (Quality Management System) elements.

Roles & Responsibilities
• You will be responsible for ensuring line clearance, material verification, startup checks and in-process checks as per the batch manufacturing and batch packing records.
• You will review and approve Master batch manufacturing and Master batch packing records.
• You will be responsible for implementation and compliance of technology transfer, and initiation of exhibit batches.
• You will be responsible for ensuring timely sampling of in-process, reserve stability and finished product samples.
• You will be responsible for ensuring the planning and execution of Media fill activities per schedule, and that the Visual Inspectors are qualified before execution of batch.
• You will be responsible for release of finished product in SAP in the absence of Head-QA (Quality Assurance).
• You will be responsible for handling of QMS elements like change control, Incident, OOS (Out of Specification), OOT (Out of Trend) and CAPA (Corrective and Preventive Actions).
• You will be responsible for review and approval of SOP’s (Standard Operating Procedure), protocols and reports related to Production and IPQA (In-Process Quality Assurance).
• You will be involved in failure investigations like batch, media fill, sterility test positive, OOS and Incidents (which impact the sterility assurance of the product) to support the SIT (Site Investigation Team).

Educational qualification: A B.Pharm. or M.Pharm/ MSc Microbiology.

Minimum work experience: 12 to 15 years of experience

Skills & attributes:

Technical Skills
• Experience in QA of line clearance, material verification, start up checks, and in-process checks following batch manufacturing and packing records.
• Experience in implementation of technology transfer and initiation of exhibit batches.
• Exposure to QMS software, specifically handling of QMS elements, including change control, Incident, OOS, OOT, and CAPA.
• Knowledge of SOPs, protocols, and reports related to Production and IPQA.
• Experience in failure investigations, such as batch, media fill, sterility test positive, OOS, and Incidents impacting the sterility assurance of the product.

Behavioural Skills
• Attention to detail and adherence to quality standards in manufacturing and quality assurance processes.
• Leadership skills for managing and qualifying Visual Inspectors and handling QMS elements.
• Effective communication and collaboration for technology transfer, exhibit batches, and failure investigations.
• Timely decision-making and release of finished products in SAP in the absence of Head-QA.

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.

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/#!/