Quality Assurance Associate – CAR-T | Biologics | Bengaluru
Job Summary:
Dr. Reddy’s Laboratories invites applications for the role of Quality Assurance Associate (CAR-T) to join its cutting-edge biologics division in Bengaluru. The position requires 2–6 years of relevant experience in cell therapy, biologics, or biopharmaceutical quality assurance. The ideal candidate will play a pivotal role in establishing and maintaining GMP-compliant systems at the new CAR-T manufacturing facility, ensuring adherence to global regulatory standards.
Key Responsibilities:
Support the establishment and maintenance of quality management systems (QMS) in compliance with cGMP.
Provide QA oversight for GMP-related activities, including operations and quality control.
Review change controls, deviations, investigations, and customer complaints.
Partner with cross-functional teams to ensure QMS compliance with regulatory and internal standards.
Oversee commissioning and qualification activities on-site.
Author, review, and approve SOPs, specifications, regulatory submissions, and controlled documents.
Participate in internal and external audits, and regulatory inspections as needed.
Ensure timely execution of QA tasks to maintain product quality and regulatory compliance.
Required Skills & Qualifications:
Education: Bachelor’s degree or higher in Pharmacy, Biotechnology, or related Life Sciences.
Experience: 2–6 years in biopharmaceutical, biologics, or cell therapy industries.
Technical Skills:
Knowledge of CAR-T or Cell and Gene Therapy products is preferred.
Strong understanding of Good Manufacturing Practices (GMP).
Familiarity with FDA, EU, and local regulatory standards.
Experience in reviewing QMS records like deviations, CAPA, change controls, and complaints.
Behavioral Skills:
Excellent communication and interpersonal skills.
Strong problem-solving and critical-thinking abilities.
Ability to work in cross-functional teams and manage multiple priorities.
Time management and attention to detail.
Perks & Benefits:
Competitive salary package (not disclosed)
Opportunities to work on cutting-edge CAR-T and biologics projects
Learning and development programs
Health and life insurance coverage
Collaborative work culture focused on innovation and scientific excellence
Career advancement opportunities within a global pharma leader
Company Description:
Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical leader dedicated to providing innovative and affordable medicines. With a presence in 66 countries and strong capabilities in biologics, formulations, and APIs, Dr. Reddy’s is committed to transforming healthcare by addressing unmet medical needs.
Work Mode:
On-site – Bengaluru, India
Call to Action:
Are you ready to drive quality excellence in the future of CAR-T therapies? Apply now to be part of Dr. Reddy’s transformative biologics journey and make an impact in cutting-edge healthcare innovation.
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