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Quality Assurance Associate (Car-T)

2-6 years
Not Disclosed
10 June 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.