Job Position: Document Control Specialist
Job Description: Ajman – Job Summary Responsible for the corporate document control process, including working directly with authors, reviewers, and approvers to facilitate document control workflow, working directly with sites to implement corporate best practices documents, and providing corporate governance. Provides end-user support for the organization and manages use of the electronic document management system (eDM). Accountable and responsible for the management of all QMS (e.g. policies, procedures, etc.) and nonQMS related documentation and records. Responsible for ensuring compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485, etc.). Principal Duties and Responsibilities Facilitates the document control process regarding new or existing Corporate Quality System Documents, nonQuality System documents, and other related records; and tracking the status of documents during the process � draft, peer review, approved, effective, obsoleted, etc. This includes working directly with authors, reviewers, and approvers to facilitate document control workflow and document archiving/retention, assisting with document formatting, ensuring proper document organization; ensuring required metadata and other applicable data inputs for compliance are provided; and tracking and trending of open tasks to facilitate timely turn-around. Conducts technical writing review of Corporate QMS documents prior to formal review process to ensure accuracy, good documentation practices, readability (clear & concise), and compliance to FDA and other standards and regulations. This includes identifying QMS gaps, providing guidance to document authors regarding how to create, or remediate or correct documents prior to their finalization and retention in the document management system or file. As Author or Process Owner, creates, modifies and obsoletes QMS documents and corporate best practices procedures and policies, and creates and provides respective training presentations …see more details
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