Job Summary
Dr. Reddy’s Laboratories Ltd. invites applications for the role of Quality Assurance Associate (CAR-T) in Bengaluru. The role focuses on overseeing GMP compliance in CAR-T cell therapy manufacturing. This is a cross-functional role interfacing with operations, QC, regulatory teams, and facility qualification activities to ensure adherence to global regulatory and company quality standards.
Key Responsibilities
Ensure implementation and maintenance of Quality Management Systems (QMS) aligned with cGMP and regulatory standards.
Provide QA oversight for cGMP-related operations and Quality Control activities.
Review quality system records, including deviations, change controls, investigations, and complaints.
Partner with cross-functional teams to ensure QMS compliance with internal and regulatory expectations.
Provide QA oversight for commissioning and qualification of new equipment and processes on-site.
Develop, author, review, and approve SOPs, specifications, regulatory filings, and controlled documents.
Participate in internal and external audits and regulatory inspections as required.
Perform additional tasks supporting product quality and cGMP compliance.
Required Skills & Qualifications
Bachelor’s degree or higher in Pharmacy or Life Sciences.
2–6 years of relevant QA experience in biopharmaceutical or cell therapy industries.
Preferred exposure to Cell and Gene therapy products.
Strong understanding of Good Manufacturing Practices (GMP).
Familiarity with FDA, EU, and local regulatory requirements.
Strong communication, problem-solving, critical thinking, and teamwork skills.
Ability to manage time effectively and prioritize tasks under strict timelines.
Perks & Benefits
Competitive salary package (Not specified).
Relocation and joining support.
Family-friendly benefits including Maternity & Paternity leave.
Comprehensive medical and life insurance coverage for self and family.
Learning and career development opportunities.
Exposure to advanced Cell & Gene Therapy technologies.
Company Description
Dr. Reddy’s Laboratories Ltd. is a globally recognized pharmaceutical leader with a focus on affordable, high-quality medicines and cutting-edge biologics. With a strong presence across 66 countries, Dr. Reddy’s is pioneering in developing novel therapies like CAR-T, aiming to impact global healthcare positively.
Work Mode
On-site – Bengaluru, India
Call to Action
Ready to make a difference in the future of Cell & Gene Therapy? Apply now and become part of a world-class pharmaceutical leader driving innovation and quality in biologics.
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