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.
Post : Quality Assurance - Cell & Gene Therapy Manager / Senior Manager
Desired Profile - Masters or PhD (Quality Assurance / Biotechnology) with less than 10 years experience. Candidate must have experience in Biologies.
• Establish and maintain the quality system standards per Schedule M for Cell and Gene Therapy R&D and GMP manufacturing sites.
• Ensure Quality Oversight to ensure consistency of standards, harmonization, sharing of best practice and productivity.
• Operational lead of CAR-T / CAR-NK QA unit staff. Ensure qualified personnel are available in QA operations for CAR-T / CAR-NK program.
• Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
• Conduct Quality reviews to evaluate if processes & deliverables fulfil the requirements for quality, to uncover deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
• Support the development and delivery of training in quality matters. Interface with other line functions involved in CAR-T to ensure Quality operations and practices are aligned with regulatory expectations in India and industry best practices.
• Prepare and follow internal authority inspections. Oversee deviations, investigations and audits.
• Interact heavily with manufacturing and QC teams, making sure products are getting released on time and within compliance.
• Involve in regulatory and customer audits and being able to work within a group, and work within a very collaborative culture.
Job Location : Bangalore
Send your resume to email@example.com
Last Date : 10th February, 2023
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