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.

• Review of master BMR/Specifications related to injectable, Biologics and Vaccine products for LL and TP mode projects.
• To check the batch release requirements for regulated markets (USA/Canada/Europe) and Emerging markets for launch products. This includes executed batch records, COAs, COCs
• Continuous monitoring and management of Review and ensure Quality Management System at contract manufacturing sites.
• Review and approval of quality notifications such as – change controls, deviations, incidents, out of trend (OOT), out of specification (OOS), market complaints etc., and carry out necessary investigation, impact assessment, risk assessment, CAPA implementation and effectiveness checks. To lead the investigation process and bring the quality issues to an appropriate conclusion.
• Execute GEMBA rounds at partner site to improve the cGMP practices at partner sites
• Performing of audits of manufacturing sites.
• Visit to manufacturing site during manufacturing and testing activity or as and when needed to monitor the manufacturing and testing operations.
• Support for ensuring the review and approval of artworks/MPCs for new products.
• Preparation and review of quality agreements with partners.
• Performing SAP transactions for QM Info creation , batch releases and approving code creations requests.
• Monitor the batch manufacturing/testing activities at CMO for new products/process validation batches.
• Review of validation protocols/validation reports/stability protocols
• Verification of check points for first pack for the new products/new packs/market extension products.
• Handling quality notifications (Change controls, incidents, deviations and OOS) and involve in investigations for critical quality issues.
• Support for Market conversion
• Timely Escalation to Lead about quality issues and stability Failures of Dr.Reddy’s marketed products.

Exp : 12+ Years 

Mandatory skills:

 Functional knowledge of Regulatory guidelines, Pharmacopoeias, Dosage form, QMS systems, knowledge of all dosage forms, Risk Analysis, Root cause analysis, CAPA, Auditing techniques and Statistical tools for evaluation.

Expected skills:

Relationship management, • Communication skills, • Leadership skills, • Analytical Abilities, • Decision making abilities, • Team Building

• Leading the team with necessary guidance to accomplish the individual and departmental goals in line with the compliance requirements.
• Ensuring the timely launches of new products from CMOs.
• Timely resolving the quality issues with coordination of CMOs.
• Defining individual employee goals in line with department level and organizational level goals.
• Handling of audit and compliance system (execution of audits of CMOs, External testing laboratories, audit of vendors)
• Supporting to Customer audits, providing response to the audit findings within the stipulated timelines and closing the audit findings with permanent measures.
• Delivering regular training sessions to the team on the current regulatory requirements.
• Participating during due-diligence activities as part of merger and acquisitions (review of product quality review, process validation report, specification &STP, site due-diligence).
• Planning and ensure the completion of routine activities as per committed timelines.
• Review and approval of Process validation, Method Transfer Protocols and Reports.
• Handling Customer Complaints and participating during investigation at CMOs and ensure appropriate CAPA implemented.
• Handling of Change controls & Incidents and actively coordinating with CMO sites for the effective implementation and Closure.
• Responding to Regulatory queries deficiencies and submitting required documents to Regulatory Affairs for Dossier filings, amendments and updates.
• Carrying out Quality Risk Assessment by using FMEA (Failure Mode Effect Analysis) technique to implement proper mitigation strategies based on the risk rating in order to improve the Right First Time Capabilities.

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. The 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