Executive, Technical Writing
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Essential Functions:
- Prepare, develop, and maintain technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
- Conduct periodic document audits to ensure ongoing compliance, traceability, and alignment with evolving regulatory requirements
- Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation
- Review 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
- Support 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
- Support training activities related to technical documentation standards and cGMP requirements as required.
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years