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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

 

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.