Legend Biotech EU
Biotechnology
QAReleaseSpecialist
“QA Release Specialist at Legend Biotech EU. Skills: Quality assurance, Regulatory compliance, Batch release. Provide quality oversight for manufacturing. Review and approve batch records”
Industry & Context.
Problem solving
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, Relevant experience in pharmaceutical industry, Relevant experience in biotech industry, Fluent English
Nice to Have
One year relevant experience, Aseptic manufacturing environment experience, Experience in GMP environment, Experience in QA environment, Knowledge of Dutch
What You'll Do.
Provide quality oversight for manufacturing
Review and approve batch records
Approve supporting documentation
Ensure GMP compliance
Ensure GDP compliance
Perform risk analyses
Initiate non-conformances
Resolve discrepancies
Take quality decisions
Ensure batches are ready for release
Ensure activities align with quality systems
Ensure activities align with safety policies
Ensure activities align with GMP regulations
Maintain documentation
Support audit readiness
Support inspection readiness
Collaborate with Operations
Collaborate with stakeholders
Gather missing information
Contribute to corrective actions
Contribute to preventive actions
Support continuous improvement initiatives
How You'll Work.
Team & Collaboration
Collaborate with Operations; Collaborate with stakeholders
Communication Scope
Clear communication
Applying for this QA Release Specialist role?
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