Job opportunity in Quality Assurance at Aurigene- Apply before 15th September 2024

Position: Sr. Executive – Quality Assurance
Location: Bangalore

About Aurigene

Aurigene, a leading biotech company and a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd., is dedicated to the discovery and clinical development of innovative therapies for cancer and inflammatory diseases. We are currently seeking a skilled professional to join our team as a Sr. Executive in Quality Assurance.

Desired Profile:

• Education: M.Sc./M.Tech/M.Pharm
• Experience: 5-10 years of experience in Quality Assurance within a GMP pharmaceutical organization.

Key Responsibilities:

AHU Qualification & Validation

• Develop and execute protocols for DQ, IQ, OQ, and PQ of clean rooms, HVAC systems, and equipment.
• Review and validate technology transfer documents.
• Review and approve batch manufacturing records.
• Oversee IPQA for dispensing, manufacturing, packaging, and dispatch processes.
• Manage change control and deviations effectively.
• Investigate and implement corrective and preventive actions (CAPAs) for OOS/OOT events.
• Maintain and update GMP validation procedures.
• Ensure compliance through regular monitoring and internal audits.

Analytical Quality Assurance

• Review analytical documents for early-stage development, technology transfer, and pilot production.
• Collaborate with QC scientists to ensure the quality of documentation.
• Support regulatory submissions by reviewing development documents.
• Possess hands-on experience in analytical method development, validation, and stability studies.
• Investigate and resolve laboratory incidents (OOS/OOT).
• Review data for adherence to specifications and test methods.
• Maintain and track departmental documents and reports.

Application Process:

Interested candidates are invited to send their resumes to apoorva_s@aurigene.com.
Application Deadline: 15th September 2024

Join Aurigene and be a part of a team that is at the forefront of groundbreaking research and development in precision oncology and immunotherapy.