Senior Executive, Technical Writing

Essential Functions

Lead the preparation, development, and maintenance of technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements Establish documentation metrics and dashboards to track quality, compliance trends, and team productivity Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation Review and approve existing documentation to identify gaps, inconsistencies, or areas requiring update and escalate findings to relevant stakeholders Ensure all technical documents accurately reflect manufacturing processes, equipment operations, and quality systems Provide guidance and review support to junior documentation staff on documentation standards and cGMP requirements Manage the document control lifecycle including creation, revision, review, approval, and archival of technical documents Maintain accurate and complete documentation records including document revision histories and change control logs Ensure all technical writing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance Prepare Process and Cleaning Validation Protocol and Reports Additional Responsibilities: Education: B.

Pharm B. Pharm

• Required M. Pharm M. Pharm
• Preferred Experience: 5 years or more in 5 - 8 Years Specialized Knowledge: Licenses: