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.
• Robust experience in analytical and process document review.
• Good understanding of biologics development, GMP, and global regulatory requirements.