
Computer System Documentation Specialist
14 hours ago
As a Computer Validation Engineer, you will play a pivotal role in developing comprehensive documentation for computerized systems validation processes.
Key Responsibilities:- Develop regulatory-compliant documentation to ensure the quality and integrity of CSV processes.
- Translate complex technical concepts into clear, concise language that meets industry standards.
- Apply your knowledge of GAMP guidelines and regulatory frameworks to ensure documentation meets strict compliance requirements.
- Collaborate with cross-functional teams to gather inputs and feedback on documentation.
- 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 identify areas for improvement.
- Bachelor's degree in computer science 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.
This role offers an excellent opportunity to grow professionally and contribute to the development of innovative solutions in the pharmaceutical and life sciences industries.
About the Role:This is a full-time position that requires strong analytical and problem-solving skills, as well as excellent communication and collaboration skills.
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