BeiGene, Ltd. is a commercial-stage biopharmaceutical company rooted in China that is dedicated to becoming a global leader in the discovery, development and commercialization of innovative, molecularly targeted and immuno-oncology drugs for the treatment of cancer.
The Document Control Specialist is responsible for managing GxP controlled documents through the development process while adhering to strict timelines, maintaining version control, and managing reviewers and approvers.
Essential Functions of the job:
Manage and maintain controlled documents in Veeva Vault QualityDocs (VVQD) including creating draft documents, maintaining profile card metadata, and linking supporting documents
Track Document Change Requests and Document Change Controls within to ensure reviews and approval are completed within strict timelines
Coordinate the review, approval, and archival of BeiGene's controlled documents in accordance with GxP regulations
Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures
Implement and utilize advanced word processing and automation features of Microsoft Office software
Build and Run reports in Veeva Vault QualityDocs to ensure accuracy and completeness of the document control process
Participate in validation testing for system implementations and updates
Manage Document Control email inbox with prompt responses to internal customers
Other duties as assigned
Adaptability Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.) Veeva vault, Compliancewire