Team Member

Rsponsible for managing the initial and periodic validation and qualification activities for various areas and facilities. This includes drug substance and drug product manufacturing equipment, cold storage equipment, utilities, media fill of aseptic areas, and smoke studies. The role requires a seasoned professional with experience in validation and qualification processes within the pharmaceutical or biotechnology industry, specifically on injectables.

Key Responsibilities:

1. Validation and Qualification Management:
2. Manage the validation and qualification activities for manufacturing equipment such as Autoclaves, Tunnels, Lyophilizers, Bioreactors, and Dry-heat Sterilizers.
3. Handle the validation and qualification of cold storage equipment including Cold Rooms, Deep Freezers, Refrigerators, Incubators, Blast Freezers, Freeze-Thaw units, and Warehouse storage areas.
4. Ensure the validation and qualification of utilities such as Water systems, Compressed air, Nitrogen, Oxygen, and Carbon Dioxide systems.
5. Aseptic Area Management:
6. Manage media fill activities to ensure aseptic conditions are maintained.
7. Conduct and oversee smoke studies to validate airflow and contamination control in aseptic areas.
8. Documentation and Compliance:
9. Develop and maintain comprehensive validation and qualification protocols and reports.
10. Ensure all activities comply with regulatory requirements and internal SOPs.
11. Maintain accurate and detailed records of all validation and qualification activities.
12. Team Leadership:
13. Lead a team of validation and qualification specialists, providing guidance, training, and performance management.
14. Foster a culture of continuous improvement and ensure the team stays updated with the latest industry standards and practices.
15. Project Management:
16. Plan, coordinate, and execute validation and qualification projects within defined timelines and budgets.
17. Collaborate with cross-functional teams including Quality Assurance, Manufacturing and Engineering.
18. Risk Management:
19. Identify potential risks in validation and qualification processes and develop mitigation strategies.
20. Conduct risk assessments and ensure corrective and preventive actions are implemented effectively.
21. Continuous Improvement:
22. Drive continuous improvement initiatives to enhance validation and qualification processes.
23. Stay abreast of industry trends, regulatory changes, and technological advancements.

Qualification

• Education: Bachelor's degree in Engineering, MSc or MPharm (Life Sciences), or a related field.
• Experience: 10-15 years of experience in validation and qualification within the pharmaceutical or biotechnology industry.
• Skills:
• Strong knowledge of validation and qualification principles and practices.
• Excellent leadership and team management skills.
• Proficiency in regulatory requirements and industry standards (e.g., FDA, EMA, GMP).
• Strong project management and organizational skills.
• Excellent communication and interpersonal skills.
• Ability to analyze complex data and make informed decisions.

Additional Requirements:

• Ability to work in a fast-paced, dynamic environment.
• Strong problem-solving skills and attention to detail.

Additional Information

About the Department

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