Team Member - Drug Substance - Downstream

Job summary

We are looking for an individual to execute downstream/upstream manufacturing unit operations ensuring documentation and compliance within GMP (Good Manufacturing Practices) regulatory and organizational guidelines. The objective is to produce products within defined volumes and timelines while maintaining compliance with quality standards GMP and other regulatory and statutory requirements as per the schedule.

Roles & Responsibilities

• Execute unit operations within Downstream/Upstream according to the BPR (Batch Production Record).
• Conduct activities to support production schedules obtain and stock supplies as required.
• Prepare media buffers and solutions necessary for unit operations.
• Perform routine cleaning and support activities in GMP Manufacturing areas.
• Perform routine process area cleaning autoclave operation manual cleaning and sterilization of components and parts.
• Monitor processes and results suggesting methods to ensure process success and interfacing with process automation systems.
• Issue discrepancies collaborate with cross-functional departments to close them implement corrective actions.
• Comply with GMP and safety standards for designated manufacturing equipment.
• Complete batch documentation in alignment with GMP ensuring data collection and maintenance meet cGMPs (Current GMP) company standards policies and regulatory requirements.
• Support timely root cause investigations and CAPA (Corrective and Preventive Actions) completion.
• Maintain manufacturing equipment for correct functionality and calibration compliance.
• Operate within validated process parameters and support qualification and validation activities.
• Emphasize safety awareness and continuous improvement.
• Adhere to safety rules and promptly report unsafe matters and near misses/accidents.

Qualifications :

Educational qualification and work experience

Educational qualification: A Graduation in Chemical Engineering or Biotechnology or a Post-Graduation in Science
Minimum work experience: 3 years of experience in working on Biosimilar Products

Skills & attributes

Technical Skills

• Comprehensive understanding of process manufacturing.
• Expertise in quality systems implementation and adherence to safety norms ensuring compliance with industry standards.
• Practical experience and hands-on knowledge of Downstream and Upstream operations.
• Knowledge of equipment and processes and proficiency in cleaning validation in the pharmaceutical manufacturing context.
• Understanding and knowledge of Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems.

Behavioural skills

• Possesses effective listening abilities fostering clear communication and understanding.
• Pays meticulous attention to detail ensuring precision in tasks and work.
• Prioritizes and is aware of deadlines ensuring timely completion of tasks.
• Demonstrates analytical skills and the ability to troubleshoot effectively.
• Possesses strong interpersonal skills and collaborates effectively within a team.

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 1015-year time horizon...

Benefits Offered

At Dr. Reddys we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddys are on par with the best industry standards...

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions...

For more details please visit our career website at Work :

No

Employment Type :

Full-time