Project Manager

Job Description

REQUIREMENTS

• Proven experience with document control within an engineering or manufacturing industry, preferably in a regulated environment such as pharmaceuticals or medical devices.
• Strong knowledge of ISO 13485 (medical device quality management), ISO 9001 (quality management systems), FDA regulations, and pharmaceutical regulatory compliance standards.
• Technical proficiency with Microsoft Office Suite (Word, Excel, PowerPoint), SharePoint, ERP systems, project management software, and document management tools.
• Excellent organizational skills with the ability to manage multiple priorities efficiently while maintaining attention to detail.
• Demonstrated experience in records management, data entry, proofreading, and technical writing.
• Familiarity with document workflow management processes including filing systems and document review procedures (document control).
• Effective cross-functional communication skills to collaborate seamlessly across departments and external stakeholders.
• Administrative experience supporting project teams or quality assurance functions is highly desirable.

RESPONSIBILITES

• Manage and maintain comprehensive document control systems, including document review, filing, and workflow management using platforms like SharePoint and document management systems.
• Oversee the creation, proofreading, and distribution of technical documents, ensuring accuracy and compliance with pharmaceutical regulatory standards.
• Coordinate project documentation processes across departments using project management software and ERP (Enterprise Resource Planning) systems to track progress and deadlines.
• Facilitate communication between engineering, quality assurance, regulatory teams, and external partners to ensure alignment on document requirements and project milestones.
• Support records management activities by organizing data entry, data management tasks, and maintaining accurate records in accordance with ISO 13485, ISO 9001, and FDA regulations.
• Assist in preparing reports, technical writing tasks, and review of documentation for compliance with legal standards in production environments.
• Contribute to continuous improvement initiatives by identifying opportunities for streamlining document workflows and enhancing document compliance practices.

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