Qualification Engineer

Job Description

Documentation Lead/Qualification Engineer

• Documentation Management: Lead the creation, review, and approval of qualification documents (DQ, IQ, OQ, PQ).
• Revision Control: Maintain effective revision control to ensure all documents are current and compliant.
• Quality Assurance: Collaborate with QA teams to meet regulatory and quality standards.
• Training and Support: Provide training on documentation practices and regulatory compliance.
• Cross-Functional Collaboration: Work with engineering and validation teams for comprehensive documentation.
• Audit Readiness: Ensure documentation is complete and accessible for audits.
• Process Improvement: Identify and implement best practices to enhance documentation workflows.
• Regulatory Compliance: Stay updated on industry regulations and align documentation practices accordingly.
• Risk Management: Assess documentation-related risks and implement corrective actions.
• Reporting: Generate reports on documentation status and compliance metrics for senior management.