Assistant Manager / Deputy Manager – Quality Assurance (Biopharmaceuticals) at Aurigene Oncology
About Company:
Aurigene Oncology, a subsidiary of Dr. Reddy’s Laboratories Ltd., focuses on discovering and developing novel cancer and inflammatory disease therapies. Our mission includes precision oncology, oral immune checkpoint inhibitors, and the Th-17 pathway.
Position:
Assistant Manager / Deputy Manager – Quality Assurance
Location:
Karnataka, India
Qualifications:
- Master’s/M.Tech in Biotechnology, Molecular Biology, or Biochemistry
- 8-12 years in the Biopharmaceutical Industry with experience in Quality Assurance
Key Responsibilities:
Quality Systems Implementation:
- Implement quality systems for GMP manufacturing activities
- Prepare and implement system SOPs in the GMP facility for regulatory compliance
Qualification and Validation:
- Prepare qualification protocols for clean room and HVAC systems
- Execute qualification activities
- Review technology transfer documents
- Coordinate validation in plant scale with cross-functional teams
Documentation and Compliance:
- Review Master Batch Manufacturing records
- Oversee change control, deviations, and CAPA implementation
Investigations and Analysis:
- Investigate OOS and OOT incidents to identify root causes using QRM tools
Training and Education:
- Conduct cGMP training sessions for employees
- Update internal departmental procedures per ICH and global regulatory guidelines
Monitoring and Compliance:
- Ensure compliance of quality systems through continuous shop floor monitoring
Application Details:
- Email: Send resume to ishita_m@aurigene.com
- Application Deadline: 15th August 2024
