Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts.
Post : Senior Executive - Quality Assurance & CMC Regulatory Affairs
Department : Development Quality Assurance & CMC Regulatory Affairs Assurance
Qualification : Masters / M.Tech (Biotechnology / Molecular Biology / Biochemistry with 6-8 years prior experience in Quality Assurance
Job Location : Bangalore
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.
• Preparation of Qualification protocols for Manufacturing equipment (DQ, FAT/SAT, IQ, OQ, PQ) 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
Interested candidates may send their updated resumes with subject line 'Application for Sr. Executive - Development Quality Assurance & CMC Regulatory Affairs Assurance' to preeti_s@aurigene.com
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