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.
Key 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.
Interested candidates may send their resume to apoorva_s@aurigene.com
Last Date : 15th September 2024
