WHAT DOES A DOCUMENT CONTROLLER DO?
Published: Dec 17, 2024 – The Document Controller develops and maintains a documentation management system to support the ERP-SAP integration project, ensuring all documentation is tracked and complies with internal and external requirements. Coordination of document review and approval processes ensures adherence to project schedules, site policies, and cGMP compliance. Continuous improvement of documentation management processes is driven, with training programs and accurate schedule updates being implemented.
A Review of Professional Skills and Functions for Document Controller
1. Document Controller Responsibilities
- Document Management: Track, transmit, and accurately file paper and electronic engineering documents, drawings, and internal and external correspondence.
- Documentation Control: Manage technical and non-technical documentation and records.
- Process Improvement: Support continuous improvement of Document Control system procedures and processes.
- Technical Drawing Understanding: Experience working with and understanding technical drawings and related documentation.
- Request Handling: Respond to internal and external documentation requests - act as the point of contact for all documentation activities within the business.
- System Integration: Transfer project documentation using client systems - including Sharepoint, Firmex, and Exostar.
- Reporting: Compile and report statistical information.
- Project Documentation: Prepare project-specific documentation, and liaise with the project team to determine the relevant document cycle.
- Clerical Tasks: Perform routine clerical tasks including data entry, scanning, distributing, and preparing documents for issue.
- Archiving: Correctly file documentation and prepare it for record archiving.
- Security Compliance: Maintain current security clearances and credentials.
2. Document Controller Accountabilities
- Documentation Management: Manage all official documentation which includes standardized procedures.
- Process Implementation: Ensure effective implementation of document control processes.
- Record Keeping: Ensure accurate records of all official documentation generated by the company.
- Data Storage: Store data in the Document Management System.
- Objective Achievement: Ensure the attainment of departmental objectives.
- Process Support: Support in analyzing, organizing, and managing Document Management processes and activities.
- Task Monitoring: Controlling and monitoring related tasks.
- Compliance Assurance: Assuring maintenance and compliance across the Company.
- Knowledge Transfer: Ensure knowledge transfer and preservation of Document Management matters across the group in line with Company best practices.
3. Document Controller Job Description
- Document Control: Transfer department design document control.
- Collaboration: Liaise with technical teams to create, update, and approve required production, quality control, and associated supporting documentation.
- Procedure Development: Produce and maintain department procedures and training modules.
- Documentation Tracking: Plan and track product documentation through later stages of BBI’s development process, through transfer and into routine manufacture.
- Compliance Management: Responsible for transferring department compliance to BBI’s quality system.
- Compliance Monitoring: Control and maintenance of Transfer compliance activities including any deviations and non-conformances plus liaison with the quality department to drive CAPA activities.
- QMS Support: Support the site QMS following ISO 13485, cGMPs (21CFR 820), and Global Quality System procedures.
- Audit Support: Support the customer audit process.
- Relationship Management: Maintain positive relationships with Site functions.
- Request Handling: Ensure site and customer requests, general queries, and requests for documentation.
- Questionnaire Completion: Complete questionnaires promptly for the scope of the department.
4. Document Controller Essential Functions
- Document Maintenance: Maintain documents and revisions to ensure a complete and up-to-date repository of information.
- Review Process Management: Manage and monitor the document review and assurance process.
- Approval Workflow Management: Manage the approval workflows.
- Document Organization: Manage classification, sorting, indexing, filing, archiving, and retrieval activities of all documentation.
- Compliance Management: Ensure compliance across all information in line with standards, protocols, and security measures.
- Process Development: Assist in the development, maintenance, and rollout of document management processes and systems.
- Administrative Support: Assist the teams with general administration.
- Quality Assurance: Take responsibility for QA checking information to company standards.
- Reporting: Collate relevant reports for the business reviews.
- Continuous Improvement: Lead and participate in Continuous Improvement projects.
5. Document Controller Role Purpose
- Documentation Management: Develop and maintain a documentation management system to coordinate and manage all documentation required to support operations and all projects across the ERP-SAP integration project.
- Tracking and Metrics: Develop and maintain trackers and tools to support metrics and tracking of documentation.
- Document Review Coordination: Coordinate internal and external review and approval of documentation to meet manufacturing and project requirements.
- Schedule Management: Proactively progress documents to achieve schedule adherence and to site policies and compliance with cGMPs.
- Document Formatting: Update and format documentation including SOPs, forms, logbooks, and label templates.
- Document Processing: Coordinate processing of documents in PDOCS.
- Point of Contact: Be a reliable point of contact for the documentation process and the current status of documents.
- Process Improvement: Responsible for implementation and continuous improvement of documentation management processes/systems.
- Schedule Updates: Ensure any relevant updates to the finite schedule are accurately reflected.
- Training Development: Develop and deploy training programs.
- Report Preparation: Assist in the preparation of reports/presentations.