Team Member MSAT injectable at Dr Reddy's Laboratories Limited

, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

13 Aug, 26

Salary

0.0

Posted On

15 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cleaning Validation, Technology Transfer, Root Cause Analysis, GMP Compliance, Risk Assessment, Change Control, Product Lifecycle Management, Protocol Preparation, Injectable Manufacturing, Non-Conformance Investigation, Regulatory Audits, Process Improvement

Industry

Pharmaceutical Manufacturing

Description

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. Job Description To handle the cleaning Validation activities for Injectable manufacturing lines. Preparation & revision of CVMP Updating and Approval of CV Matrix. Preparation and Review of Cleaning Validation related Checklists, Protocol and Reports and its related assessments/training (as applicable). Implementation of new applications related to Cleaning Validation. Provide support for troubleshooting, root cause analysis and product impact assessments for non-conformance investigations and process changes/improvements. Support for regulatory audits. Initiation, review and approval of Change controls, Incidents, Process comparision and risk assessment with respect to Validation / qualification activities. Co-ordination with CFTs (i.e. Production, QA, QC) for tracking and execution and various documentation. Training of employees. Review change controls Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM). Initiate, change controls, incidents, and risk assessments related to technology transfer activities. Support technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products. Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments. Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements Qualifications Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy 4 to 8 years of relevant experience Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. 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/#!/ Job Family: Engineering & Science Sub Job Family: Technology Transfer - Parenteral Preferred type of working: On-Premise Years of Experience: 6 - 12 Business unit: IPDO

Responsibilities

Manage cleaning validation activities for injectable manufacturing lines, including the preparation of protocols, reports, and CV matrices. Support technology transfer, product lifecycle management, and root cause analysis for non-conformance investigations.