
Data Documentation Specialist
2 weeks ago
The role of a CSV technical writer is crucial in ensuring that complex documentation is presented in a clear and accessible manner.
Key Responsibilities:
- Develop comprehensive documentation for CSV processes to meet regulatory requirements.
- Communicate technical concepts effectively to diverse stakeholders.
- Apply industry-specific knowledge to ensure compliance with GxP and GAMP 5 standards.
- Collaborate with cross-functional teams to gather inputs and feedback.
- Document functional and compliance requirements through user stories.
- Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.
- Manage change control processes and prepare CAPA reports.
Requirements:
- Bachelor's degree in computer science or related field (Master's preferred).
- Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain.
- Strong understanding of CSV principles and regulatory frameworks.
- Excellent writing, editing, and stakeholder engagement skills.
- Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.
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