Team member - MSAT
- Technology Transfer - OSD
- Pydibimavaram
- IPDO
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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 a detail-oriented and collaborative Team Member for our Manufacturing Science and Technology (MSAT) department in Pydibimavaram, India. This role is crucial in ensuring smooth execution of various batches, from confirmatory to validation, and supporting process optimization and scale-up activities.
- Execute and monitor confirmatory, trial, scale-up, exhibit, pre-validation, validation, and placebo batches
- Demonstrate successful process scale-up for timely execution of confirmatory, exhibit, pre-validation, and validation batches
- Prepare and review essential documents such as Master Formulation Records (MFR), Process Instructions Sheets (PIS), sampling plans, and master production records
- Perform scale-up correlations for all unit operations from lab to plant scale
- Analyze data and provide support in addressing process-related regulatory deficiencies
- Prepare and review protocols and reports for hold time studies, submission batches, Process Performance Qualification (PPQ), and stability studies
- Coordinate with cross-functional teams to ensure timely completion of activities
- Conduct investigations, prepare detailed reports, and recommend appropriate corrective and preventive actions (CAPA) for submission and validation batches
- Plan and execute trials to identify probable root causes of issues
- Initiate change control procedures as required for batch execution
- Support cleaning verification and validation activities
- Master's degree in Pharmacy
- 3-7 years of experience in Process Development, Technology Transfer, or MSAT
- Proven expertise in process development, scale-up, and technology transfer of solid dosage forms
- Strong understanding of pharmaceutical process selection and optimization
- Proficiency in preparing technical protocols and reports
- Experience with process engineering and risk assessment approaches
- In-depth knowledge of ICH guidelines and other relevant regulatory requirements
- Familiarity with statistical software and data analysis techniques
- Solid background in analytical research and data interpretation
- Excellent communication and interpersonal skills
- Strong analytical and problem-solving abilities
- Performance-oriented mindset with a focus on continuous improvement
- Ability to work collaboratively within a team and across functions
- Commitment to learning and coaching team members
- Familiarity with Good Manufacturing Practices (GMP)
- Knowledge of regulatory requirements in pharmaceutical manufacturing
- Willingness to work in Pydibimavaram, India
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