Team Member DP - QMS and Material Management
- Full-time
- Job Family: Manufacturing
- Sub Job Family: Production - OSD
- Preferred type of working: On-Premise
- Business unit: Biologics
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 candidate to oversee manufacturing and production operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise.
Roles & Responsibilities
• You will be responsible for handling line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing.
• You will be responsible for handling equipment like Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water system, compressed air, Nitrogen system, etc.
• You will be responsible for process validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
• You will evaluate change controls, deviation, and incident, (OOS) out of specification, (OOT) out of trend, and risk management.
• You will prepare the production process SOPs (Standard Operating Procedures) and batch records.
• You will provide training on GMP (good manufacturing practices).
• You will apply knowledge of aseptic processes, Lean, OEE (Overall Equipment Effectiveness), and similar KPIs (Key Performance Indicators).
• You will respond to queries and questions regarding regulatory audits such as US FDA (Food and Drug Administration).
Qualifications
Educational qualification: A Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related field
Minimum work experience: 7 years of experience in pharmaceutical manufacturing operations
Skills & attributes:
Technical Skills
• Expertise in line operations, especially in manufacturing activities like CIP, SIP, and batch manufacturing.
• Proficiency in understanding equipment such as Steam Sterilizer, Dry heat sterilizer, HVAC, water system, compressed air, Nitrogen system, etc.
• Understanding of Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
• Knowledge for evaluation of change control, deviation, incident, out of specification, out of trend, and risk management.
• Experience in preparing production process SOPs and batch records.
• Understanding and application of Aseptic processes, Lean, OEE, and similar KPIs.
• Hands-on experience in regulatory audits, particularly with agencies like the US FDA.
• Good understanding of GMP and good laboratories practice.
Behavioural skills
• Capacity to provide training on GMP and other relevant areas.
• Collaborates seamlessly with cross-functional teams, promoting a cooperative and inclusive work environment.
• Efficiently manages time to meet production schedules and deadlines without compromising quality.
• Must have hands-on experience in sophisticated manufacturing machine and equipment.
• Effective communication and training skills for user departments and service providers.
Additional Information
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.
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/#!/
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