A company is looking for a Senior Quality Assurance Officer (GDP).
Key Responsibilities
Prepare product and batch release documentation and support batch disposition
Lead internal audits and support external vendor and regulatory audits
Manage deviations, complaints, temperature excursions, CAPAs, and Change Controls
Required Qualifications
Bachelor's degree in a relevant field, ideally (bio)pharmaceutical
At least 4 years of pharmaceutical QA experience
Strong knowledge of EU GMP, GDP, and related legislation
Experience with QMS systems, internal audits, and batch review
Skilled in root cause analysis, CAPA, and Quality Risk Management
Quality Assurance Officer • Austin, Texas, United States