Team Member - QA CTO

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 an individual for the Quality Assurance team, responsible for overseeing various quality assurance activities to ensure compliance with regulatory requirements and maintain product quality. Your responsibilities will include managing change notifications, conducting investigations, handling market complaints, coordinating audits, and supporting regulatory filings.

Roles & Responsibilities
• You will be responsible for managing change notifications, ensuring timely processing and implementation of changes as per SOP.
• Preparation and thorough review of Annual Review Reports to assess product quality and compliance status.
• Handling incidents, out-of-specification (OOS), and out-of-trend (OOT) occurrences, including investigation, resolution, and documentation.
• Managing market complaints, return goods, and recalls, ensuring proper investigation and implementation of corrective actions.
• Coordinating internal and external audits, including regulatory and customer audits, ensuring compliance with audit requirements and timely response to findings.
• Providing data promptly to compile monthly reports and support corporate initiatives, contributing to organizational goals and performance objectives.
• Performing SAP activities and updating Bills of Materials (BOM) and recipes accurately to reflect product specifications and changes.
• Overseeing training activities, ensuring employees receive necessary training to perform their roles effectively and comply with quality standards.
• Reviewing and approving Quality Risk Management processes to identify, assess, and mitigate risks to product quality and patient safety.
• Managing Corrective and Preventive Actions (CAPAs), from initiation to closure, to address quality issues and prevent recurrence.
• Ensuring timely submission of documents for Drug Master File (DMF) filings, including new submissions, amendments, and annual updates, in coordination with Regulatory Affairs.
• Supporting marketing queries and DMF filings, including responding to deficiencies in submissions and updates.
• Ensuring compliance with good manufacturing practice, GxP, and other regulatory requirements through self-training and adherence to established procedures.
• Conducting vendor qualification activities to assess and approve vendors based on quality and regulatory criteria.
• Reviewing and approving layouts to ensure compliance with regulatory and quality standards for facility design and operations.

Educational qualification: A Bachelor’s degree in  Chemistry, Chemical Engineering, or a related field

Minimum work experience: 3 to 7 years of experience in pharmaceutical manufacturing or a similar role

Skills & attributes:

Technical Skills
• Knowledge of microbiology and aseptic practices, cleaning validation activities, sampling and relevant standards.
• Proficiency in performing line clearance, material verification, start-up checks, and in-process checks following batch manufacturing and packing records.
• Experience in timely sampling and testing of in-process, reserve, and finished samples, as well as stability samples and environmental monitoring.
• Skilled in reviewing batch manufacturing and batch packing records, ensuring accuracy and certification after execution.

Behavioural Skills
• Attention to detail in performing line clearance, verification, and record reviews.
• Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities.
• Communicates effectively with team members and stakeholders regarding batch-related activities and compliance.
• Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification.
• Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

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/#!/