Work as Assistant Manager / Deputy Manager - Quality Assurance at Aurigene Oncology

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 : Assistant Manager / Deputy Manager - Quality Assurance (Biopharmaceuticals)

Desired Profile : Masters / M.Tech (Biotechnology/Molecular Biology/Biochemistry with prior experience in Quality Assurance) with 8 -12 years’ in Biopharmaceutical Industry.

Key Responsibilities
• Implement quality systems for GMP manufacturing activities.
• Prepare, implement system SOPs in GMP facility to ensure compliance as per regulatory requirements.
• Preparation of Qualification protocols for clean room qualification, HVAC (Heating ventilation and air conditioning) systems and execution of qualification activity.
• Review of technology transfer documents and initiate the validation accordingly in plant scale by coordinating with CFT.
• Review of Master Batch Manufacturing records executed Batch manufacturing records.
• Oversee change control, Deviations and follow-up with CFT members for effective and timely implementation of CAPA.
• Investigate against OOS and OOT, encountered for root cause identification/analysis (RCA) through QRM tools.
• Conduct cGMP training sessions to educate all employees for better understanding of regulatory requirements.
• Maintain and update internal departmental procedure in accordance with ICH and global regulatory guidelines.
• Ensuring compliance of quality systems by continuous monitoring on shop floor.