About this role
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: