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Posted 15 hours ago
QA Release Specialist
Legend BiotechQA Release Specialist
Requirements
Bachelor's degree in Life Sciences, Experience in pharma or biotech, Fluent English, GMP knowledge preferred
Skills
GMPQuality AssuranceSAP
About the role
Responsibilities
- Review and approve production batch records and supporting documentation to ensure compliance with GMP and GDP standards
- Evaluate deviations, perform risk analyses, and initiate non-conformities
- Make quality decisions in SAP S/4 to ensure batches are ready for technical release
- Ensure all activities align with quality systems, safety guidelines, and GMP regulations
- Collaborate with Operations and stakeholders to ensure timely and compliant batch release
- Support continuous improvement initiatives for batch review processes and lead times
Requirements
- Bachelor's degree in Life Sciences or equivalent relevant experience in pharma or biotech
- Preferably at least one year of experience in an aseptic production environment
- Experience in a GMP and/or QA environment is a strong asset
- Fluency in English (spoken and written) is required
- Knowledge of Dutch is a plus
Preferred Qualifications
- Experience with SAP S/4
- Background in aseptic manufacturing
Benefits
- Meaningful job with good work-life balance
- Flexible scheduling options (4/4 shift regime or standard Monday-Friday)
- Permanent contract (onbepaalde duur)
- Attractive salary package with performance bonus and double holiday pay
- Comprehensive benefits including meal vouchers, group and hospitalization insurance, and a company laptop
- Opportunities for personal development and working with global colleagues
About the Company
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies, including treatments for persistent diseases such as cancer.
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Legend Biotech · Ghent
