Pharmaceutical and Life Sciences Documentation Specialist
1 day ago
At a leading pharmaceutical company, we are seeking a detail-oriented Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.
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.
- Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.
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