Document Controller

We are seeking a highly organized and detail-oriented Document Controller to support our team on a pharmaceutical manufacturing facility build project. The ideal candidate will manage and maintain project documentation, ensuring that all documents are up-to-date, easily accessible, and properly stored. You will play a key role in ensuring compliance with industry standards and regulatory requirements by facilitating accurate document control processes.

Key Responsibilities

Document Management: Organize, manage, and maintain project documentation, including engineering drawings, contracts, specifications, procedures, and reports. Ensure documents are appropriately numbered, categorized, and filed for easy access and retrieval.
Control and Distribution: Coordinate the distribution of controlled documents to internal teams, contractors, and external stakeholders. Ensure that all recipients are working with the most up-to-date versions of project documentation.
Compliance and Audits: Ensure all documentation complies with relevant regulatory requirements such as FDA regulations, Good Manufacturing Practices (GMP), and industry standards. Support internal and external audits by providing timely and accurate documentation.
Document Version Control: Manage version control of all project documentation, ensuring changes and updates are properly logged and tracked. Ensure that document revisions are clearly identifiable and accessible.
Project Coordination: Collaborate with project managers, engineers, and other stakeholders to support the timely delivery of project documentation. Ensure that document control processes align with the overall project schedule.
System Implementation: Utilize document management systems (DMS) to ensure efficient document storage, retrieval, and sharing. Support the development and improvement of document control processes and systems.
Record Retention: Maintain and archive all project-related documents in accordance with company and industry policies. Ensure proper retention and disposal procedures are followed for all records.
Reporting: Generate reports on document control activities, including document status, pending approvals, and distribution metrics. Provide regular updates to project teams and management on document-related issues.
Training and Support: Train and support project team members on document control systems and procedures. Ensure that team members understand how to use the document management system and adhere to document control policies.
Continuous Improvement: Identify and implement improvements to document control processes. Stay informed of best practices and evolving regulatory requirements in document management for pharmaceutical manufacturing projects.

Requirements

Qualifications

Bachelor’s degree in Information Management, Business Administration, or a related field. Relevant certifications in document control or records management are a plus.
Minimum of 10 years of experience in document control, preferably in a pharmaceutical or construction project environment. Familiarity with managing documentation for large-scale facility build projects is highly desirable.
Proficiency with document management systems (e.g., SharePoint, Aconex, or similar platforms). Strong knowledge of version control, metadata management, and document security practices.
Familiarity with FDA regulations, GMP, and other pharmaceutical industry standards. Understanding of documentation requirements for regulatory submissions and audits.
Excellent organizational skills, attention to detail, and ability to handle multiple tasks simultaneously. Strong communication skills and the ability to work collaboratively in a fast-paced project environment.

Preferred Qualifications

Experience with electronic document management systems (EDMS) in the pharmaceutical or construction industry.
Knowledge of ISO 9001 or similar quality management systems.
Certification in Document Control (e.g., IQDCS or equivalent).

Soft Skills

Cross-Cultural Communication
Adaptability and Flexibility
Team Collaboration and Interdisciplinary Skills
Problem-Solving and Critical Thinking
Emotional Intelligence
Time Management and Prioritization
Ethical Awareness and Sustainability Focus
Conflict Management
Stakeholder Engagement
Continuous Learning Mindset

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General Information

Vacancy: 024

Location: Europe

Contract type: 1 year rolling contract, consulting contract.

Project duration: 1-2 years.

How to Apply?

If you’re interested in this role, we’re looking forward to hear from you! Kindly apply via the JTR Consultancy Services website with your CV in Word Document version – one of our Business Development Managers will be in touch with you shortly.