
CSV Documentation Specialist
3 days ago
We are seeking a skilled professional to fill the role of a CSV Technical Writer.
- This position requires strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.
The successful candidate will be responsible for developing comprehensive and regulatory-compliant documentation for CSV processes.
Main 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.
- Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.
- Document change control processes and prepare CAPA reports.
To be considered for this position, candidates must possess:
- A 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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