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Job Description
The Quality Assurance Document Control Specialist role at Legend Biotech supports the document management process within a cell therapy manufacturing facility in a sterile GMP environment. This role ensures compliance within the document management system, document storage and retention, and document issuance and reconciliation.
Role involves:
- Managing document control systems and processes.
- Reviewing new and revised procedures and documents.
- Supporting Document Management system users.
- Managing the periodic review process for procedures.
- Issuing batch-related documentation.
- Reconciling GMP documentation.
- Creating and issuing GMP logbooks.
- Storing and archiving GMP documents and batch-related records.
Requirements:
- Undergrad, secondary degree, or equivalent experience.
- GxP Quality System knowledge.
- Operational experience with electronic quality systems.
- Experience with Document Management Systems (TruVault/Veeva) is preferred.
- Strong written and verbal communication skills.
- Analytical problem-solving and conflict resolution skills.
- Strong organization skills and attention to detail.
- Proficient knowledge of Microsoft Office.
- Language Requirements Dutch and technical English
Role offers:
- Opportunity to work in a sterile GMP environment.
- Chance to drive continuous improvement.
- Exposure to a fast-paced and dynamic, growing environment.
