Team Lead - Drug Product QMS

Team Lead - Drug Product QMS

Company Description

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.

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Job Description

Job summary

We are looking for a meticulous professional to lead QMS of drug product manufacturing, ensuring adherence to Current Good Manufacturing Practice (cGMP) and safety norms.

" Roles & Responsibilities

• Should be capable of leading the team towards QMS elements which includes handling of deviations, OOS, market complaints, CAPA management, Risk assessments, change controls,  protocols, reports, discrepancies, batch and packaging records closures.
• Driving the improvement projects in the drug product.
• Should be leading the team for All time audit readiness and should be writing the responses to audit observations.
• Reviewing and approving SOPs, protocols, reports, discrepancies, change requests, CAPA (Corrective and Preventive Actions), QRM (Quality Risk Management), and batch and packaging records.
• Collaborating with cross-functional departments to close discrepancies and implement corrective actions, ensuring compliance with relevant GMP (Good Manufacturing Practices), safety standards, and SOPs for designated manufacturing equipment.
• Completing batch documentation in compliance with GMP, collecting and maintaining data, and participating/leading in quality and safety investigations to address and improve CAPA for drug product manufacturing.
• Engaging in continuous improvement activities, adhering to safety rules, and reporting any unsafe matters or near misses/accidents."

Qualifications

Minimum 10+ years of experience with qualification in B.Pharmacy/M.Pharmacy/B.Tech/M.Tech biotechnology 

Experience Level

Senior Level