
CSV Validation Specialist
2 days ago
CSV Validation Specialist
We're looking for a skilled technical professional to develop comprehensive and regulatory-compliant documentation for CSV processes.
Key Responsibilities:
- Develop high-quality documentation that meets GxP and GAMP 5 standards.
- Translate complex technical concepts into clear, accessible language for diverse stakeholders.
- Apply industry-specific knowledge to ensure documentation accuracy.
- Draft precise user stories reflecting functional and compliance requirements.
- Create and maintain technical documentation including validation plans, security plans, VSRs, SOPs.
Qualifications:
- Bachelor's degree in computer science, life sciences, 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, GAMP guidelines, and regulatory frameworks.
- Excellent writing, editing, and stakeholder engagement skills.
- Familiarity with data integration and analysis, and Azure Databricks platforms.
Benefits:
This role offers opportunities for professional growth and development in a dynamic and challenging environment.
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