
Technical Documentation Specialist
2 days ago
Job Title: Technical Documentation Specialist
">Job Summary:
The ideal candidate will possess strong documentation capabilities, effective communication, and deep knowledge of the pharmaceutical industry. They will have experience in stakeholder management, user story writing, and technical documentation including validation plans, security plans, VSRs, SOPs, change management, and CAPA.
Key Responsibilities:
- Develop comprehensive and 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.
- Document change control processes and prepare 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.
- Familiarity with Data Integration and Analysis, and Azure Databricks platforms.
About the Role:
This is an excellent opportunity for a skilled technical writer to make a meaningful contribution to our organization. The successful candidate will be responsible for developing high-quality documentation that meets regulatory requirements.
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