
CSV Documentation Specialist
1 week ago
Develop Regulatory-Compliant Documentation
">At our organization, we are seeking a skilled and detail-oriented technical writer to develop comprehensive documentation for CSV processes. The ideal candidate will have strong knowledge of regulatory requirements and industry-specific standards.
">Key Responsibilities:">- ">
- Translate complex technical concepts into clear language for diverse stakeholders.">
- Apply industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.">
- Collaborate with cross-functional teams to gather inputs and feedback.">
- Draft precise user stories reflecting functional and compliance requirements.">
- Document change control processes and prepare CAPA reports.">
- ">
- 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, GAMP guidelines, and regulatory frameworks.">
- Excellent writing, editing, and stakeholder engagement skills.">
- Knowledge of Data Integration and Analysis.">
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