
CSV Technical Documentation Specialist
1 week ago
Looking for a detail-oriented technical writer to create comprehensive documentation for CSV processes. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.
Key Responsibilities:- Develop regulatory-compliant documentation for CSV processes.
- Translate complex technical concepts into clear, accessible 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 and actionable user stories reflecting functional and compliance requirements.
- Create and maintain technical documentation including validation plans, security plans, VSRs, SOPs, change management, and CAPA reports.
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.
- Knowledge of data integration and analysis, and familiarity with Azure Databricks platforms.
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