About this role
Description:
This role is responsible for leading and executing technical writing activities within a regulated pharmaceutical manufacturing environment, ensuring that all technical documents including standard operating procedures, work instructions, technical reports, and related materials are accurate, comprehensive, and compliant with current Good Manufacturing Practices and applicable regulatory requirements. The position takes a senior role in the creation, review, and revision of technical documents that describe manufacturing processes, equipment operations, and quality systems, ensuring clarity and regulatory compliance. It ensures that all technical writing activities are conducted in strict adherence to document control procedures and regulatory standards. The role collaborates with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation. It provides guidance and review support to junior documentation staff and participates in cross-functional initiatives to improve documentation quality and efficiency. Accurate and timely completion of technical writing tasks is a core accountability of this position. The role participates in process improvement initiatives and functional team projects aimed at enhancing documentation quality, efficiency, and compliance. It operates within a highly regulated pharmaceutical environment, ensuring all technical documents meet defined quality and regulatory standards.
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
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: