Work as Quality Assurance Sr. Executive at Aurigene

Aurigene is a development stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, and a wholly owned subsidiary of Dr. Reddy's Laboratories Ltd. Aurigene is focused on precision - oncology, oral immune checkpoint inhibitors, and the Th-17 pathway.

Post : Sr. Executive - Quality Assurance

Location : Bangalore
Desired Profile : M.Sc./M.Tech/M.Pharm with prior experience in Quality Assurance with 5-10 years' in GMP pharmaceutical organization

Roles & Responsibilities
AHU Qualification & Validation
• Develop and execute protocols for DQ, IQ OQ, and PQ of clean rooms, HVAC, and equipment
• Review and validate technology transfer documents.
• Review and approve batch manufacturing records.
• Oversee IPQA for dispensing line clearance, manufacturing, packaging and dispatch.
• Manage change control and deviations.
• Investigate and implement CAPAs for OOS/OOT events.
• Maintain and update GMP validation procedures.
• Ensure compliance through monitoring and audits.
Analytical Quality Assurance
• Review analytical documents for earty-stage development, technology transfer, and pilot production.
• Ensure document quality through collaboration with QC scientists.
• Support regulatory submissions by reviewing development documents.
• Possess hands-on knowledge of analytical method development; validation, and stability studies.
• Investigate and resolve laboratory incidents (OOS/OOT).
• Review data for specifications and test methods.
• Maintain and track departmental documents and reports.