Document Controller

1. Job Title
Document Controller

2. Job Overview
Reporting to the Quality manager, the Document Controller is responsible for the administration and maintenance of Orphalan’s documentation management and contract approval system ensuring that controlled documents and records are managed throughout their lifecycle in accordance with company policies and procedures and applicable GxP requirements.
The role supports the effective operation of the Quality Management System (QMS) by maintaining inspection-ready documentation, administering the electronic QMS, and collaborating with business owners and cross-functional departments to ensure timely document review, approval, implementation, retention, and archival

3. Responsibilities and duties
Specific responsibilities include, but are not limited to:

Documentation
• Manage controlled documents and records throughout their lifecycle, from creation and approval through implementation, revision, retention, archival, and destruction.
• Ensure all controlled documents are maintained in accordance with company procedures and regulatory requirements.
• Upload, issue, archive, and maintain documents within the electronic Quality Management System
• Maintain document registers, master lists, and archival systems.
• Ensure employees have access to the latest approved versions of documents.
• Coordinate document reviews and monitor periodic review timelines.

Contract Administration
• Administer the contract approval process and associated electronic tools.
• Coordinate the circulation, review, approval, execution, and archival of contracts and agreements.
• Maintain an accurate repository and index of quality agreements, technical agreements, commercial contracts, and associated records.
• Support business owners throughout the contract approval workflow and ensure documentation is complete and appropriately filed.

eQMS Management
• Act as system administrator for document control activities within the QMS
• Maintain user access, document workflows, and system records as required.
• Generate reports and metrics related to document status, approvals, training, and compliance.
• Support continuous improvement of document management processes and systems.

Cross-Functional Collaboration
• Work closely with business owners and cross-functional departments to ensure timely preparation, review, approval, and implementation of documentation.
• Provide guidance and support on document control requirements and processes.
• Assist with training employees on document control processes, the contract approval process, and the use of the QMS

Audit and Inspection Support
• Support internal audits and regulatory inspections.
• Ensure requested documentation is readily accessible and provided in a timely manner.
• Maintain documentation systems in a continuous state of audit and inspection readiness.
• Assist with the tracking and retrieval of records required for audits and inspections.

4. Qualifications
• 5 years’ experience in document control, records management or quality administration within a regulated environment is preferred.
• Experience administering electronic document management systems or QMS platforms
• IT Skills, including competency in Sharepoint and Microsoft Office applications.
• Strong organisational skills and timekeeping
• Strong verbal and written communication skills.
• Team worker with good collaboration skills
• Self-starter with ability to take initiative.

Key Competencies
• Organisation and planning
• Attention to detail
• Communication and collaboration
• Customer service mindset
• Compliance focus
• Problem-solving
• Accountability and ownership
• Continuous improvement