Specialist - DQA, CDMO Biologics

Aurigene Pharmaceutical Services Limited; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Aurigene Pharmaceutical Services Limited in Hyderabad is seeking a senior Development Quality Assurance (DQA) professional for Biologics with 10+ years of QA experience to oversee GMP-compliant development activities and ensure regulatory alignment.

You will review analytical and process development documents, support audits, and collaborate with Analytical Development, Process Development, Manufacturing and Regulatory Affairs teams to maintain quality standards and regulatory readiness.

Qualifications

• MSc/PhD in Biotechnology, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field.
• 10+ years of Development QA experience in biologics/biosimilars.
• Strong knowledge of GMP, regulatory requirements, and documentation review.

Responsibilities

• Review and approve analytical and process development documents.
• Ensure compliance with FDA, EMA, ICH, and GMP requirements.
• Support audits, inspections, and quality risk management activities.
• Work closely with Analytical Development, Process Development, Manufacturing, and Regulatory Affairs teams.

Skills

QA Oversight

Documentation Review

GMP Compliance

Risk Management

Education

MSc/PhD in Biotechnology/Biochemistry/Microbiology

Job description

Development Quality Assurance (DQA) - Biologics

Experience: 10+ Years

Role Summary:

Provide quality oversight for Biologics development activities and ensure compliance with GMP, regulatory requirements, and internal quality systems.

Key Responsibilities:

• Review and approve analytical and process development documents.
• Review method validation, process validation, technology transfer, deviations, CAPAs, and change controls.
• Ensure compliance with FDA, EMA, ICH, and GMP requirements.
• Support audits, inspections, and quality risk management activities.
• Work closely with Analytical Development, Process Development, Manufacturing, and Regulatory Affairs teams.

Qualifications:

• M.Sc./Ph.D. in Biotechnology, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field.
• 10+ years of experience in Development QA/Quality Assurance within Biologics/Biosimilars.
• Strong experience in analytical and process document review.
• Good understanding of biologics development, GMP, and global regulatory requirements.