Pharmaceutical Technical Documentation Specialist
20 hours ago
This role involves creating comprehensive and regulatory-compliant documentation for CSV processes, translating complex technical concepts into clear language for diverse stakeholders, and applying industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.
The ideal candidate will have a strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks, as well as excellent writing, editing, and stakeholder engagement skills. A Bachelor's degree in computer science, Life Sciences, or related field (Master's preferred) is also required.
Key responsibilities include:
- Developing validation plans, security plans, VSRs, SOPs, and other technical documents
- Collaborating with cross-functional teams to gather inputs and feedback
- Drafting precise and actionable user stories reflecting functional and compliance requirements
Experience with data integration and analysis, as well as familiarity with Azure Databricks platforms, is highly desirable.
Benefits:
- Opportunity to work on high-profile pharmaceutical projects
- Chance to develop expertise in CSV and technical documentation
- Collaborative and dynamic work environment
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