Quality Assurance Associate - MES

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.

We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves quality oversight of DS manufacturing facilities, reviewing real-time investigations, ensuring smooth batch manufacturing, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

• Expertise in Supporting cross functional team of MES Specialists by providing a QA perspective with regards to DS manufacturing processes, documentation requirements, and overall design of records.
• Accountable for maintaining project timelines associated with quality assurance initiatives.
• Having knowledge and hands on experience on MES application on the aspects of both designing of M ’s and its execution in order to have a brief understanding on how the recipe (design) functions during execution.
• Reviewing and approving MES recipes, master batch records, and electronic records to meet the requirements of manufacturing and QA users.
• Identifying errors in designs and suggesting alternatives way forwards that are aligned with GMP & compliance.
• Reviewing MES change controls, MES related SOPs, work instructions, forms, Assessment reports & QRA’s.
• Collaborating in the creation, review, and approval of E ’s with CFT’s.
• Support audits, inspections, investigations and CAPA management related to MES.
• Providing end-user support for MES usage and working closely with IT to troubleshoot problems associated with QA functions.
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug substance operations; where current documents are not adequate, identify path forward for establishment of procedures.
• Develop, write, review, and approve SOPs and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
• Working with Technical Trainers to develop QA training plans for MES users.
• Provide mentorship during on-the-floor manufacturing
• DS QA/ IPQA responsibilities such as support in PCO’s, line clearances, oversight activities, shop floor visit,…