Job Description

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.